Lower risk Medical device recall · FDA · Published October 31, 2024

BD COR GX Instrument Model 443990: Unauthorized Access Risk

Becton Dickinson recalls BD COR GX Instrument model 443990 due to potential unauthorized access to product data. Affected units have specific serial numbers and catalog numbers. No action is required but security credentials should be updated.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0589-2025Medical device Becton Dickinson ›

Lower-risk recall

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling a specific model of their BD COR GX Instrument (model 443990) because some technical support credentials were accessed by unauthorized individuals. This could lead to security breaches affecting product data. The recall does not require immediate action but involves updating security credentials. Read more at govinfonow.com/recall/53603-bd-cor-gx-instrument-model-443990-unauthorized-access-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53603-bd-cor-gx-instrument-model-443990-unauthorized-access-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0589-2025

Cite this page

“BD COR GX Instrument Model 443990: Unauthorized Access Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53603-bd-cor-gx-instrument-model-443990-unauthorized-access-risk. Based on FDA recall #Z-0589-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2025%22&limit=1).

The FDA announced on Oct. 31, 2024, that Becton Dickinson & Co. is recalling BD COR GX Instruments due to a cybersecurity risk involving unauthorized access to product service credentials. The agency issued recall number Z-0589-2025 for the voluntary Class II action affecting 70 units distributed worldwide.

How to tell if you have it

Brand: Becton Dickinson
Product: BD COR GX Instrument
Model/Catalog Number: 443990
UDI-DI: 00382904439903
Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207

The hazard

Becton Dickinson confirmed that product service credentials used by some technical support teams to access certain BD products were accessed by an unauthorized actor. Until these credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include BD Kiestra Isolate Suspension Cuvette Array (Oct. 23, 2025) and BD GasP: CO2 Pouch System (April 7, 2026). Similar recent cybersecurity-related recalls include Philips Azurion X-Ray System (June 17, 2026), GE Medical Systems Centricity Universal Viewer Software (Jan. 30, 2026), and Boston Scientific Intracept Access Instruments (April 22, 2026).

How to tell if you have this one

Check if your BD COR GX Instrument has the model number 443990 and the listed serial numbers or catalog number 443990. The instrument may have a unique identifier (UDI-DI) starting with 00382904439903.

Brand
Becton Dickinson
Category
Medical device

FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.

Recall number	Product, codes & lots	Quantity
Z-0584-2025	BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007; Catalog No: 441007; UDI-DI: 00382904410070; Serial Number: This software version was not serialized. Distribution quantities unable to be determined.	Software
Z-0585-2025	BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887; Catalog No: 440887; UDI-DI: 0382904408879; Serial Numbers: 6GF3TD2, 2MJHML1, 697JFF3, HSB9WV1, YL00QYF9, GMWYLN2, 1TR5JL2, GD6XCP2, HGKCXQ2, FH62RP2, GDBZCP2, GD92DP2, CPQ77X2, H3JQ3Y2, 20HJ4Z2, 5D2BSZ2, DXMWG13, DXP1H13, DXQTG13, GL2MZB3, 15XTT52, 3WZ7S52, B1HJSD2, HDQBND2, GL2RZB3, 6977NF3, 697CNF3, 6P9P704, 1TT5JL2, GMVYLN2, GD9ZCP2, GDC0DP2, GDBYCP2, 1TS5JL2, 1TT4JL2, FH42RP2, 5LVX7M2, 5LVY7M2, FH51RP2, FH43RP2, GD6ZCP2, 1TV2JL2, 5LWV7M2, 5LWY7M2, GD70DP2, GD91DP2, 5LWZ7M2, 5D27SZ2, 5D33SZ2, 4Q40H03, GMSM9N2, FH40RP2, CPQ67X2, CPQ57X2, H3LJ3Y2, H3KF3Y2, HM2YDX2, CPQ87X2, 91TGPY2, 91TFPY2, 91THPY2, 91TLPY2, GPWS9Z2, GPVP9Z2, 5D24SZ2, 5D25SZ2, 5D26SZ2, 5D35SZ2, GPTR9Z2, GPWP9Z2, GPTS9Z2, GPXP9Z2, 4Q41H03, 5D28SZ2, DXR0H13, 4Q44H03, DXNXG13, GPVS9Z2, 4Q56H03, 4Q4ZG03, DXNVG13, 4Q55H03, B1GMSD2, DXPZG13, 3PDNH03, 3PDMH03, 16LQT52, DXPXG13, DXPYG13, DXPTG13, DXQXG13, DXNWG13, DXP2H13, GPWR9Z2, 4Q3ZG03, HM2XDX2, JTBGK02, GD9ZYQ1, JCN5T52, JCN3T52, 2MLHML1, HSBMWV1, 1H0T8Z1, 15QRT52, 15RTT52, 15VMT52, 163QT52, 16BNT52, 15QPT52, 16NST52, 16PPT52, CN46C42, CN66C42, 3X05S52, 15RST52, 51P1Q22, 3X00S52, B1HLSD2, HDQ8ND2, HDSCND2, HDS5ND2, HDQ9ND2, HDS7ND2, HDS6ND2, HDR9ND2, GL2TZB3, GL2NZB3, GL2SZB3, H3KQ3Y2, GKRRZB3, GKRQZB3, 6979NF3, HM23FX2, 4J65ST3, JH65ST3, 698CNF3, 3J65ST3, 6989NF3, 5C685K3, JWZN8N3, 9Y0WDZ3, 20MDDZ3, 22MDDZ3, 40MDDZ3, 72MDDZ3, 80MDDZ3, JX0WDZ3, 62MDDZ3, D0MDDZ3, 91MDDZ3, F0MDDZ3, 8Y0WDZ3, C1MDDZ3, 9C685K3, BZLDDZ3, FZLDDZ3, BY0WDZ3, 51MDDZ3, J0MDDZ3, 5Y0WDZ3, H0MDDZ3, HZLDDZ3, 41MDDZ3, G1MDDZ3, FH5ZQP2, 1TW3JL2, FH53RP2, HGK9XQ2, FH60RP2, HM2ZDX2, H3KL3Y2, H3LK3Y2, H3LM3Y2, 20HK4Z2, 5D2DSZ2, DXN0H13, DXQSG13, DXNTG13, DXN1H13, 6986NF3, 788P704, 1TX2JL2, 1TR3JL2, GDB1DP2, GD9XCP2, 6LCTXK2, FH5YQP2, 5LW08M2, 5LXV7M2, GMWWLN2, GMRYLN2, GDBXCP2, FH41RP2, FH4ZQP2, GMXM9N2, 5LWW7M2, FH50RP2, 3PCVH03, 5D29SZ2, 20HM4Z2, 5D34SZ2, HGKBXQ2, GD9YCP2, FH52RP2, CPP97X2, H3KP3Y2, H3LL3Y2, H3LF3Y2, H3LG3Y2, 91TJPY2, 91TMPY2, 91T24Z2, 20HN4Z2, GPVR9Z2, 5D36SZ2, GPWQ9Z2, 3PCQH03, GL2PZB3, 4Q4YG03, H3KH3Y2, 4Q53H03, 4Q52H03, DXQ0H13, DXMZG13, 4Q51H03, 4Q54H03, 4Q36H03, 4Q35H03, DXPSG13, 4Q42H03, 4Q43H03, DXQ2H13, 3PCTH03, 3PCRH03, DXN2H13, DXQYG13, JBRH842, DXNZG13, 4Q45H03, 4Q3YG03, JTBPK02, 67FJYR1, 4RSJPS1, 2MJLML1, JBRJ842, CV1MYQ1, 111ZZ12, 1H0S8Z1, JCN0T52, GD9XYQ1, JBRD842, 1H0V8Z1, 4C214J1, 15XST52, 15STT52, 15SMT52, 15XRT52, 163ST52, 16NPT52, 16LST52, CN44C42, 16PMT52, 16NNT52, CN54C42, CN56C42, 51N1Q22, 15VPT52, 15QNT52, 15SNT52, B1HHSD2, B1GHSD2, B1GLSD2, B1GKSD2, HDSBND2, B1HKSD2, HDT5ND2, HDRCND2, HDR6ND2, GL2LZB3, GL2QZB3, GL2JZB3, 6987NF3, 6978NF3, 6988NF3, 3C685K3, 5Q2NWX3, FP2NWX3, JP2NWX3, H0YXMW3, 8C685K3, FX4CSY3, 11MDDZ3, 12MDDZ3, DZLDDZ3, H1MDDZ3, 21MDDZ3, 2Y0WDZ3, 30MDDZ3, 31MDDZ3, 42MDDZ3, 1Y0WDZ3, 81MDDZ3, CY0WDZ3, C0MDDZ3, G0MDDZ3, 5D23SZ2, 6Y0WDZ3, B0MDDZ3, JZLDDZ3, F1MDDZ3, D1MDDZ3, 52MDDZ3, 3Y0WDZ3, 50MDDZ3, 4P9P704, 588P704, 8ZLDDZ3, BP9P704, 5P9P704, CP1LS42, 7Q0TZ4J, 1DGSB5J, BLHT5Y1, 6T78J4J, BLK2002, 2LBM25J, JYCM022, 3CY5302, 15100040406, 4QCX55J, BDPHKY1, 2LF4H92, MG4208EC, B1BG75J, GKBM25J, 35L3ZZ1, 9GK2002, F95CV02, 2JBM25J, B9H2002, 7GQVV22, 35RWXK2, 3XST4S2, 1JK2002, BXS2DY1, 36RYXK2, 3680YK2, HYCF8R1, JJS2422, 34TT4S2, 3672YK2, 2X0H302, 2PM5WL2, 36NXXK2, 375ZXK2, FXK3ZZ1, 27DRS22, 36C0YK2, 373XXK2, 3445959961, B0K25R2, 32ST4S2, 377YXK2, 58KV4R2, 1XF8H32, CVST4S2, 36XXXK2, 3RVHCD2, 9F2Q022, B5TT4SU, 36PZXK2, 2XF1H32, FV09C5J, J0ST4S2, 36MWXK2, H97M022, JCB6H32, D2TT4S2, 36GXXK2, 6CPHKY1, DWF2H32, D5ST4S2, F9TT4S2, 6YST4S2, 91TT4S2, 84ST4S2, JQST4S2, 5LST4S2, C8ST4S2, 37TT4S2, 50ST4S2, JMST4S2, FSST4S2, JCST4S2, 98TT4S2, 2CTT4S2, 2PST4S2, 85F9D33, 8BST4S2, 1ZRT4S2, 8JST4S2, F4F9D33, 8FST4S2, 7CCZJ03, 65F9D33, 74f9d33, 1MBM25J, B5F9D33, 1KBM25J, JRPN215003FN, 4FB7H32, JWF1H32, G6YE51600028, D8HF5Y1, 34F9D33, H77M022, 45F9D33, 85RD6X1, 485CV02, 3XF8H32, CZC4324TPN, 36H695J, G6YE50600028, JFGSB5J, FBG5B5J, CDFV86J, DGHJS3J, 4XWHS22, HKJF45J, 999N6X1, JPOTZ4J, 7JMP5Y1, HROTZ4J, 8S78J4J, 8W6F45J, 2LWYP4J, CVF1H32, 775CV02, 8LZ7W4J, 85CPY4J, J6KS5Y1, GQ5Z05J, 597M022, F9GSB5J, 3SML5Y1, EPICLIENT3 G99N6X1, B67M022, EPICLIENT4 DHHF5Y1, 2CPBC4J, 4W8N6X1, Non-BD1, C1HF5Y1, J4CPY4J, C9GSB5J, 9NZ7W4J, EPICLIENT1 (2GPHKY1), 8LWYP4J, 3FPHKY1, JW09C5J, DB5CV02, J9GSB5J, D65CV02, 3C9N6X1, D77M022, 14RD6X1, 30DM022, CV8N6X1, 1WF1H32, HC9N6X1, 3FB7H32, 27KS5Y1, 4FB4H32, DDY5302, HWF2H32, BN1LS42, 7HY0302, 1XF7H32, 7W1LS42, 6WF5H32, 7XF5H32, 7NMN5Y1, 2728975037, 3Q58J4J, 6KWYP4J, G6YE502008J9, GQ58J4J, GS78J4J, BGPHKY1, 37CPY4J, JS78J4J, 3PCX55J, J7H695J, 8J1MZ2J, 1207S4J, 2007S4J, 1DX925J, 1LJF45J, JW6F45J (4NJF45J), FLJF45J, FW6F45J, 96H695J, 4CGSB5J, 9W09C5J, DM7BD5J, HKWYP4J, CDPHKY1, 57KS5Y1, 9HMP5Y1, 6FY5302, GX4CV02, F57M022, J47M022, 52DM022, FDB7H32, 6HY3302, 3WF6H32, JHJLS42, 8JY4302, 3M1LS42, 897M022, 1QCX55J, JRGF5Y1, 8T4CV02, DYGF5Y1, 8ZCM022, CJXZ202, 77H695J, 6MJF45J, 8NJF45J, 86H695J, 2DGSB5J, 3FGSBJ, 3M7BD5J, 6P7BD5J, GFPHKY1, HFPHKY1, 5XGF5Y1, B77M022, F47M022, 3VF8H32, 7FB0H32, DKBM25J, 87CPY4J, 6TTNT02, 8NMSGM2, 9RDTZ4J, 7HCNC2J, 4LJF45J, JD9N6X1, HWF8H32, 689BQ1J, HDB5H32, 3WVVPV3, FKVVPV3, 9KVVPV3, FWVVPV3, 65Y9ZM3, 7GHJS3J, DGY3302, 7XF6H32, G6MY639006F5, H4HF5Y1, D6H6951, JG1MZ2J, HJ1MZ2J, 1N7BD5J, CFGSB5J, CJGF5Y1, D0MQ5Y1, G6BE023012H6, G6BE10600CNW, 19623664047, 5N18BR2, HY6Q6J3, HP58J4J, 125JR53, DTY12548970JB/256644, 525JR53, J3K202, S4X7826, HTYDG42, 7K487R3, 7112PT3, 50DRS22, 5657062465, 5657062358, 5657543449, 6675843579, 79drs22, F59KSK3, C60VZ4J, 9ML4VK3, 69NR214, 047C16B4809A, DPTMPT3, 5BWQXK3, 7S061N3, 1PL4VK3, NKS-000165130, NKS-000161126, NKS-000159124, 8CF1DQ3, 1RPNW14, 6QNNW14, 4L9FY3J, 4LW204L, FX4CV02, 8B2M70J, BMZ7W4J, 46CPY4J, CGHJS3J, 3WF2H32, JBFVB2J, 534P61J, BHHJS3J, G5CPY4J, H007S4J, F107S4J, 4NZ7W4J, 8DB1H32, 1NJF45J, 4MJF45J, 23RD6X1, 6HY4302, 8XF4H32, 625CV02, 895CV02, 8XF0H32, 8YCM022, 8V0K022, 3SOTZ4J, 61ZZ7X1, 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JR5002015002, 13NGXR1, 13CHXR1, MJPZNNZ, 8CG927012P, 8GPWMS1, 99Q24V1, FDCTFP2, 8G2BM63, 6ZRV1R1, 8GV0NS1, G6MY646007ZK, 88ZRSD2, 13NHXR1, 37KRDC1, DX85GQ1, 451Q482, 13L9XR1, G1WRDC1, J6YB8P1, 64QB382, 8GQXMS1, F1WRDC1, 4-SYK382, 64PJ382, G1Y0NS1, C1WRDC1, 452W482, 64NL382, G7KRDC1, 8GQ0NS1, 451R482, 64PH382, G200NS1, 13GFXR1, 64PC382, 64QC382, 9DN34V1, 57KRDC1, 64QD382, 452O582, 13LFXR1, G1ZVMS1, 452M482, 452Q482, 6ZQKIR1, 9B824V1, 451Z482, 452V482, DLJMJS1, 42WRDC1, 451T482, 64PD382, 13GCXR1, GK8RDC1, 64PG382, 64PL382, DLQJJS1, H6BLJS1, 64NG382, 451S482, 9P2RDC1, 9DVX3V1, 64PM382, 9B1W3V1, 99R14V1, BD53ZQ1, 64NH382, CFR07Y1, HFL7LF1, 2NJS5V1, 451W482, H0Z7K02, 8PZRDC1, 93Z5QC1, 64PB382, EPSN0014, D1WRDC1, 1BZNPS1, 64PF382, EPSN0094, JZL6QC1, HZL6QC1, 64NK382, EPSN0153, G1YVMS1, HK8RDC1, 64NM382, EPSN0123, 2L56SD1, 9B404B1, 64NJ328, EPSN0204, 6ZNL1R1, FGTL6D1, 64PK382, EPSN0175, 1BWPS1, BZL6QC1, 144L821, EPSN0029, 2YSL6D1, 4J565D1, 9C2Y3V1, EPSN0065, 1BVLPS1, DGTL6B1, FWHJWH1, EPSN0163, 6V92BG1, 4JL7LF1, 4CDFTJ1, EPSN0048, C3Z5QC1, GZNL1R1, 8HR4W1, EPSN0190, JVM91F1, DDL7LF1, MXL8501RXX, EPSN0181, 2PG06V1, FDL7LF1, MXL93121QY, EPSN0202, CZL6QC1, CXSL6D1, MXL9364GZ8, EPSN0031, 9FF24V1, 99RW3V1, MJ03ZHJ6, EPSN0081, 2NGX5V1, 83Z5QC1, C8SQDB2, EPSN0148, D7RXFC1, 1P571F1, PBO2ECMY, EPSN0151, 2PBQ5V1, 1BTKPS1, PBO2ECLL, EPSN0221, 2PF06V1, 6R571S1, PBO2ECJD, EPSN0230, FL32VG1, 71GH6Y1, JQQC3Y2, EPSN0222, 8YJL601, 1V92BG1, 128sqw1, EPSN0134, 4982BG1, BL866T, MJ0H9AMX, EPSN0098, 2YCF701, 95BD8D1, MXL0013LL1, EPSN0001, 99W14V1, 6982BG1, MXL9414DJS, EPSN0030, 1BYNPS1, BWHJWH1, MXL0013LL5, EPSN0131, 5M32VG1, BL32VG1, 5H2SZ02, EPSN0095, CNNKLJ1, 9V92BG1, EPSN0064, AXCF701, 182Y5V1, 14VV7R1, EPSN0061, 74Y2VG1, GL32VG1, EPSN0082, 5PNKLJ1, 2NVZ5V1, EPSN0037, JVJHWH1, F2DX301, EPSN0185, HVHJWH1, F4Y2VG1, EPSN0025, 99T04V1, GYQN301, EPSN0058, FNNKLJ1, 2NTQ5V1, 7C4Y781, EPSN0133, 181V5V1, 1XHJWH1, EPSN0159, 9PNKLJ1, 2PJT5V1, BZFCP41, EPSN0023, 71PJ6Y1, 8FVSM01, 14Y3642, EPSN0195, 4QQM3K1, H982BG1, HMDSRR1, EPSN0223, 8QQM3K1, GWHJWH1, 8NNYHM1, EPSN0170, 88THVH1, DXVSM01, 23VV7R1, EPSN0092, 71YK6Y1, HL32VG1, 107712, EPSN0087, JW0QGX1, 88NLLJ1, EPSN0069, 895FVH1, 1PNJKL1, EPSN0140, 99DJVH1, 2NRR5V1, EPSN0017, G7NLLJ1, 71FK6Y1, EPSN0201, B0GKVH1, 78NLLJ1, EPSN0077, 38NLLJ1, DPNKLJ1, EPSN0021, BPNKLJ1, EPSN0207, 88RFTVH1, 71FL6Y1, EPSN0019, 9N82V21, 99RX3V1, EPSN0138, 895GVH1, J7NLLJ1, EPSN0074, 99BMVH1, 9DLX3V1, EPSN0108, DK15JL1, 999JVHW, 7FPL2V1, EPSN0034, 898GVH1, 2FSNS81, BRG311F3LJ, EPSN0129, B0CMVH1, 99CMVH1, BRJ425C90J, EPSN0141, 2TVSM01, 71HH6Y1, BRG345F06F, EPSN0149, 181X5V1, 28NLLJ1, BRJ428F1, EPSN0072, B0FKVH1, 4LPL3K1, EPSN0120, D50YWL1, 18NLLJ1, EPSN0143, 88YGVH1, 135GXR1, EPSN0166, C0RV8Y1, JW0QFX1, EPSN0176, 2RFGWL1, 88RHVH1, B69ZFN1, EPSN0144, CQQM3K1, JW0MGX1, HLWMZ02, EPSN0084, 1Z6LF41, JW0PFX1, G844RF1, EPSN0056, C5OYWL1, 13BGXR1, B844RF1, EPSN0009, 71QK6Y1, 2QQM3K1, EPSN0171, 650YWL1, GR7LF41, Service Tag - Verificar, EPSN0155, 71KK6Y1, JPQM3K1, EPSN0111, CF217T1, 1BTLPS1, EPSN0012, 6L15JL1, 99CLVH1, 7JL1ZD1, EPSN0097, CY6LF41, JKPL3K1, 6KL1ZD1, EPSN0038, 7PFGWL1, 5QRWVH1, EPSN0026, FNFGW1, 897HVH1, 7GKGD61, EPSN0006, C9L1XL1, 71XH6Y1, HLDSRR1, EPSN0112, 363PL02, 897GVH1, 1C4Y7S1, EPSN0158, 6ZQK1R1, 4T7LF41, 284Y7S1, EPSN0160, FKPQN22, 71QJ6Y1, MXL7520PNB, EPSN0127, FKXDN22, DTFGWL1, JR5002013063, EPSN0110, FL0TN22, B9L1XL1, JR5002013065, EPSN0198, FKYRN22, CFJ07Y1, 3CR33002TL, EPSN0200, FKSGN22, 363SL02, FF0477EPI, EPSN0142, FKQSN22, 34FQL02, JR5002015005, EPSN0174, FL0FN22, 353RL02, MXL5510RG2, EPSN0137, GK15JL1, 35WNL02, MXL6191BN2, EPSN0214, F88FN22, 363TL02, 1CZ1130CCK, EPSN0172, 4XXJS22, DLHMJS1, 1CZ1130CC5, EPSN0073, 4XX9S22, 13TL8Z1, MXL7411G1L, EPSN0003, 82XKS22, H13BK02, MXL6452G5N, EPSN0173, FKWSN22, 351PL02, MXL7411G4Y, EPSN0136, 834CS22, 35BQL02, MXL7191DWL, EPSN0208, 8FJJS22, 35DQL02, MXL7281VX4, EPSN0219, 831CS22, 2NWW5V1, MXL8101P8V, EPSN0154, 6ZNX1R1, CFH07Y1, MXL8501RXP, EPSN0126, 5JXJCP1, FKLFN22, MJ07PV03, EPSN0226, BD21ZQ1, FKLGN22, MXL3282GQQ, EPSN0187, 30VXKM1, FKPFN22, MXL33617HS, EPSN0211, 4172NM1, 2YF2FQ1, MXL307090F, EPSN0041, JCB2NM1, 143K8Z1, MXL5500SX0, EPSN0046, JCB1NM1, 32J0M02, MXL4491CM1, EPSN0013, FWCL581, FKQFN22, EpiFX0046, EPSN0184, JC9VKN1, F89DN22, MXL4412SFN, EPSN0224, 4151NM1, FKJGN22, MXL42608HJ, EPSN0055, 30RZKM1, FKGRN22, 4CS42602GB, EPSN0116, 30KXKM1, 8FJ8S22, MXL5500SX1, EPSN0091, 30WXKM1, 82XNS22, MXL6191BM1, EPSN0063, 753H5M1, 82YHS22, MXL61919RR, EPSN0210, 40Z0NM1, 8FHMS22, MXL61919RP, EPSN0078, 7JG1M51, 6WCLS81, MXL71513R4, EPSN0161, G5S30B1, 2PGX5V1, MXL7281VQL, EPSN0043, 2M23FQ1, 553H5M1, MXL0013LL2, EPSN0225, 9WCLS81, 9JG1M51, MXL6450XY0, EPSN0217, 5TGSCP1, 9HB2H41, JR5002017014, EPSN0188, OT7570, 4113NM1, MXL91125T6, EPSN0196, 9HG1M51, 30KXLM1, JR5002017006, EPSN0015, 48F2NM1, 550PS81, 8VZK613, EPSN0239, 5TGTCP1, 5TGRCP1, 25YSRZ2, EPSN0233, 5THHCP1, 5DSNS81, 25YQRZ2, EPSN0240, 14DL8Z1, 4173NM1, MXL9222016, EPSN0236, 71GL6Y1, 2Y71FQ1, MXL9222031, EPSN0249, 2JL7LF1, F5S30B1… Full codes in the FDA record	7,974 units (2,517 US, 5,457 OUS)
Z-0586-2025	BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981; Catalog No: 440981; UDI-DI: 00382904409814; Serial Numbers: 6GF3TD2, 2MJHML1, 697JFF3, HSB9WV1, YL00QYF9, GMWYLN2, 1TR5JL2, GD6XCP2, HGKCXQ2, FH62RP2, GDBZCP2, GD92DP2, CPQ77X2, H3JQ3Y2, 20HJ4Z2, 5D2BSZ2, DXMWG13, DXP1H13, DXQTG13, GL2MZB3, 15XTT52, 3WZ7S52, B1HJSD2, HDQBND2, GL2RZB3, 6977NF3, 697CNF3, 6P9P704, 1TT5JL2, GMVYLN2, GD9ZCP2, GDC0DP2, GDBYCP2, 1TS5JL2, 1TT4JL2, FH42RP2, 5LVX7M2, 5LVY7M2, FH51RP2, FH43RP2, GD6ZCP2, 1TV2JL2, 5LWV7M2, 5LWY7M2, GD70DP2, GD91DP2, 5LWZ7M2, 5D27SZ2, 5D33SZ2, 4Q40H03, GMSM9N2, FH40RP2, CPQ67X2, CPQ57X2, H3LJ3Y2, H3KF3Y2, HM2YDX2, CPQ87X2, 91TGPY2, 91TFPY2, 91THPY2, 91TLPY2, GPWS9Z2, GPVP9Z2, 5D24SZ2, 5D25SZ2, 5D26SZ2, 5D35SZ2, GPTR9Z2, GPWP9Z2, GPTS9Z2, GPXP9Z2, 4Q41H03, 5D28SZ2, DXR0H13, 4Q44H03, DXNXG13, GPVS9Z2, 4Q56H03, 4Q4ZG03, DXNVG13, 4Q55H03, B1GMSD2, DXPZG13, 3PDNH03, 3PDMH03, 16LQT52, DXPXG13, DXPYG13, DXPTG13, DXQXG13, DXNWG13, DXP2H13, GPWR9Z2, 4Q3ZG03, HM2XDX2, JTBGK02, GD9ZYQ1, JCN5T52, JCN3T52, 2MLHML1, HSBMWV1, 1H0T8Z1, 15QRT52, 15RTT52, 15VMT52, 163QT52, 16BNT52, 15QPT52, 16NST52, 16PPT52, CN46C42, CN66C42, 3X05S52, 15RST52, 51P1Q22, 3X00S52, B1HLSD2, HDQ8ND2, HDSCND2, HDS5ND2, HDQ9ND2, HDS7ND2, HDS6ND2, HDR9ND2, GL2TZB3, GL2NZB3, GL2SZB3, H3KQ3Y2, GKRRZB3, GKRQZB3, 6979NF3, HM23FX2, 4J65ST3, JH65ST3, 698CNF3, 3J65ST3, 6989NF3, 5C685K3, JWZN8N3, 9Y0WDZ3, 20MDDZ3, 22MDDZ3, 40MDDZ3, 72MDDZ3, 80MDDZ3, JX0WDZ3, 62MDDZ3, D0MDDZ3, 91MDDZ3, F0MDDZ3, 8Y0WDZ3, C1MDDZ3, 9C685K3, BZLDDZ3, FZLDDZ3, BY0WDZ3, 51MDDZ3, J0MDDZ3, 5Y0WDZ3, H0MDDZ3, HZLDDZ3, 41MDDZ3, G1MDDZ3, FH5ZQP2, 1TW3JL2, FH53RP2, HGK9XQ2, FH60RP2, HM2ZDX2, H3KL3Y2, H3LK3Y2, H3LM3Y2, 20HK4Z2, 5D2DSZ2, DXN0H13, DXQSG13, DXNTG13, DXN1H13, 6986NF3, 788P704, 1TX2JL2, 1TR3JL2, GDB1DP2, GD9XCP2, 6LCTXK2, FH5YQP2, 5LW08M2, 5LXV7M2, GMWWLN2, GMRYLN2, GDBXCP2, FH41RP2, FH4ZQP2, GMXM9N2, 5LWW7M2, FH50RP2, 3PCVH03, 5D29SZ2, 20HM4Z2, 5D34SZ2, HGKBXQ2, GD9YCP2, FH52RP2, CPP97X2, H3KP3Y2, H3LL3Y2, H3LF3Y2, H3LG3Y2, 91TJPY2, 91TMPY2, 91T24Z2, 20HN4Z2, GPVR9Z2, 5D36SZ2, GPWQ9Z2, 3PCQH03, GL2PZB3, 4Q4YG03, H3KH3Y2, 4Q53H03, 4Q52H03, DXQ0H13, DXMZG13, 4Q51H03, 4Q54H03, 4Q36H03, 4Q35H03, DXPSG13, 4Q42H03, 4Q43H03, DXQ2H13, 3PCTH03, 3PCRH03, DXN2H13, DXQYG13, JBRH842, DXNZG13, 4Q45H03, 4Q3YG03, JTBPK02, 67FJYR1, 4RSJPS1, 2MJLML1, JBRJ842, CV1MYQ1, 111ZZ12, 1H0S8Z1, JCN0T52, GD9XYQ1, JBRD842, 1H0V8Z1, 4C214J1, 15XST52, 15STT52, 15SMT52, 15XRT52, 163ST52, 16NPT52, 16LST52, CN44C42, 16PMT52, 16NNT52, CN54C42, CN56C42, 51N1Q22, 15VPT52, 15QNT52, 15SNT52, B1HHSD2, B1GHSD2, B1GLSD2, B1GKSD2, HDSBND2, B1HKSD2, HDT5ND2, HDRCND2, HDR6ND2, GL2LZB3, GL2QZB3, GL2JZB3, 6987NF3, 6978NF3, 6988NF3, 3C685K3, 5Q2NWX3, FP2NWX3, JP2NWX3, H0YXMW3, 8C685K3, FX4CSY3, 11MDDZ3, 12MDDZ3, DZLDDZ3, H1MDDZ3, 21MDDZ3, 2Y0WDZ3, 30MDDZ3, 31MDDZ3, 42MDDZ3, 1Y0WDZ3, 81MDDZ3, CY0WDZ3, C0MDDZ3, G0MDDZ3, 5D23SZ2, 6Y0WDZ3, B0MDDZ3, JZLDDZ3, F1MDDZ3, D1MDDZ3, 52MDDZ3, 3Y0WDZ3, 50MDDZ3, 4P9P704, 588P704, 8ZLDDZ3, BP9P704, 5P9P704, CP1LS42, 7Q0TZ4J, 1DGSB5J, BLHT5Y1, 6T78J4J, BLK2002, 2LBM25J, JYCM022, 3CY5302, 15100040406, 4QCX55J, BDPHKY1, 2LF4H92, MG4208EC, B1BG75J, GKBM25J, 35L3ZZ1, 9GK2002, F95CV02, 2JBM25J, B9H2002, 7GQVV22, 35RWXK2, 3XST4S2, 1JK2002, BXS2DY1, 36RYXK2, 3680YK2, HYCF8R1, JJS2422, 34TT4S2, 3672YK2, 2X0H302, 2PM5WL2, 36NXXK2, 375ZXK2, FXK3ZZ1, 27DRS22, 36C0YK2, 373XXK2, 3445959961, B0K25R2, 32ST4S2, 377YXK2, 58KV4R2, 1XF8H32, CVST4S2, 36XXXK2, 3RVHCD2, 9F2Q022, B5TT4SU, 36PZXK2, 2XF1H32, FV09C5J, J0ST4S2, 36MWXK2, H97M022, JCB6H32, D2TT4S2, 36GXXK2, 6CPHKY1, DWF2H32, D5ST4S2, F9TT4S2, 6YST4S2, 91TT4S2, 84ST4S2, JQST4S2, 5LST4S2, C8ST4S2, 37TT4S2, 50ST4S2, JMST4S2, FSST4S2, JCST4S2, 98TT4S2, 2CTT4S2, 2PST4S2, 85F9D33, 8BST4S2, 1ZRT4S2, 8JST4S2, F4F9D33, 8FST4S2, 7CCZJ03, 65F9D33, 74f9d33, 1MBM25J, B5F9D33, 1KBM25J, JRPN215003FN, 4FB7H32, JWF1H32, G6YE51600028, D8HF5Y1, 34F9D33, H77M022, 45F9D33, 85RD6X1, 485CV02, 3XF8H32, CZC4324TPN, 36H695J, G6YE50600028, JFGSB5J, FBG5B5J, CDFV86J, DGHJS3J, 4XWHS22, HKJF45J, 999N6X1, JPOTZ4J, 7JMP5Y1, HROTZ4J, 8S78J4J, 8W6F45J, 2LWYP4J, CVF1H32, 775CV02, 8LZ7W4J, 85CPY4J, J6KS5Y1, GQ5Z05J, 597M022, F9GSB5J, 3SML5Y1, EPICLIENT3 G99N6X1, B67M022, EPICLIENT4 DHHF5Y1, 2CPBC4J, 4W8N6X1, Non-BD1, C1HF5Y1, J4CPY4J, C9GSB5J, 9NZ7W4J, EPICLIENT1 (2GPHKY1), 8LWYP4J, 3FPHKY1, JW09C5J, DB5CV02, J9GSB5J, D65CV02, 3C9N6X1, D77M022, 14RD6X1, 30DM022, CV8N6X1, 1WF1H32, HC9N6X1, 3FB7H32, 27KS5Y1, 4FB4H32, DDY5302, HWF2H32, BN1LS42, 7HY0302, 1XF7H32, 7W1LS42, 6WF5H32, 7XF5H32, 7NMN5Y1, 2728975037, 3Q58J4J, 6KWYP4J, G6YE502008J9, GQ58J4J, GS78J4J, BGPHKY1, 37CPY4J, JS78J4J, 3PCX55J, J7H695J, 8J1MZ2J, 1207S4J, 2007S4J, 1DX925J, 1LJF45J, JW6F45J (4NJF45J), FLJF45J, FW6F45J, 96H695J, 4CGSB5J, 9W09C5J, DM7BD5J, HKWYP4J, CDPHKY1, 57KS5Y1, 9HMP5Y1, 6FY5302, GX4CV02, F57M022, J47M022, 52DM022, FDB7H32, 6HY3302, 3WF6H32, JHJLS42, 8JY4302, 3M1LS42, 897M022, 1QCX55J, JRGF5Y1, 8T4CV02, DYGF5Y1, 8ZCM022, CJXZ202, 77H695J, 6MJF45J, 8NJF45J, 86H695J, 2DGSB5J, 3FGSBJ, 3M7BD5J, 6P7BD5J, GFPHKY1, HFPHKY1, 5XGF5Y1, B77M022, F47M022, 3VF8H32, 7FB0H32, DKBM25J, 87CPY4J, 6TTNT02, 8NMSGM2, 9RDTZ4J, 7HCNC2J, 4LJF45J, JD9N6X1, HWF8H32, 689BQ1J, HDB5H32, 3WVVPV3, FKVVPV3, 9KVVPV3, FWVVPV3, 65Y9ZM3, 7GHJS3J, DGY3302, 7XF6H32, G6MY639006F5, H4HF5Y1, D6H6951, JG1MZ2J, HJ1MZ2J, 1N7BD5J, CFGSB5J, CJGF5Y1, D0MQ5Y1, G6BE023012H6, G6BE10600CNW, 19623664047, 5N18BR2, HY6Q6J3, HP58J4J, 125JR53, DTY12548970JB/256644, 525JR53, J3K202, S4X7826, HTYDG42, 7K487R3, 7112PT3, 50DRS22, 5657062465, 5657062358, 5657543449, 6675843579, 79drs22, F59KSK3, C60VZ4J, 9ML4VK3, 69NR214, 047C16B4809A, DPTMPT3, 5BWQXK3, 7S061N3, 1PL4VK3, NKS-000165130, NKS-000161126, NKS-000159124, 8CF1DQ3, 1RPNW14, 6QNNW14, 4L9FY3J, 4LW204L, FX4CV02, 8B2M70J, BMZ7W4J, 46CPY4J, CGHJS3J, 3WF2H32, JBFVB2J, 534P61J, BHHJS3J, G5CPY4J, H007S4J, F107S4J, 4NZ7W4J, 8DB1H32, 1NJF45J, 4MJF45J, 23RD6X1, 6HY4302, 8XF4H32, 625CV02, 895CV02, 8XF0H32, 8YCM022, 8V0K022, 3SOTZ4J, 61ZZ7X1, 685CV02, 4N5Z05J, 9XF2H32, DDJLS42, 7Y1LS42, 71MQ5Y1, 6P1LS42, 2HJLS42, 4KBM25J, 1XK2G5J, BVGF5Y1, JRMK5Y1, HDPHKY1, 3FHF5Y1, 5LHT5Y1, 3JXZ202, 3KY0302, 3Z4CV02, 2VF4H32, JVLRNT3, 2JYWG4J, 20RD6X1, G6YE50200BML, G4RD6X1, 887M022, HWF7H32, FVF1H32, 65y92m3, BWVVP3, 4WVVPV3, 7WVVPV3, 9WVVPV3, CLB563, 4DCL5T3, 7KVVPV3, HVVVPV3, GVVVPV3, G6MYBD500G6R, BTDN951001ER, FD9N6X1, JN7BD5J, FB9N6X1, GG1MZ2J, 1GGSB5J, FKZ7W4J, G6MY803008KD, 91KJS12, CHMP5Y1, FZCM022, JCPHKY1, BW6F45J, G6FN144002AC, G6FN203008TU, Epicenter Workstation Europe - 629SJ32, 7Y1P8X2, 47N8SP2, JMLS6Z2, 256644 - Epicenter Workstation Europe - J4F2002, 68FLQB3, 5C35S63, 469KSK3, 68drs22, HWD8Y4J, NKS-000121113, 5PTMPT3, C112PT3, G0M1FM3, 3XTHZ4J, CHB87GRT, 124YTG00155, 80HG654, 6L487R3, C3BFF73, 83BFF73, 55BFF73, DR9FF73, PC1EBE9W, 236AWLQ1, FL487R3, JML4VK3, DBF1DQ3, 1RL4VK3, JDF1DQ3, BDF1DQ3, 6RMFBW3, 6ZRX1R1, 2P9W5V1, E108281751000001, H150H01, BDB3ZQ1, 26GN9Y1, MT-M1853-A5G, C0RD6X1, 6ZPX1R1, 6ZQL1R1, SAA70907WL, JR5002015002, 13NGXR1, 13CHXR1, MJPZNNZ, 8CG927012P, 8GPWMS1, 99Q24V1, FDCTFP2, 8G2BM63, 6ZRV1R1, 8GV0NS1, G6MY646007ZK, 88ZRSD2, 13NHXR1, 37KRDC1, DX85GQ1, 451Q482, 13L9XR1, G1WRDC1, J6YB8P1, 64QB382, 8GQXMS1, F1WRDC1, 4-SYK382, 64PJ382, G1Y0NS1, C1WRDC1, 452W482, 64NL382, G7KRDC1, 8GQ0NS1, 451R482, 64PH382, G200NS1, 13GFXR1, 64PC382, 64QC382, 9DN34V1, 57KRDC1, 64QD382, 452O582, 13LFXR1, G1ZVMS1, 452M482, 452Q482, 6ZQKIR1, 9B824V1, 451Z482, 452V482, DLJMJS1, 42WRDC1, 451T482, 64PD382, 13GCXR1, GK8RDC1, 64PG382, 64PL382, DLQJJS1, H6BLJS1, 64NG382, 451S482, 9P2RDC1, 9DVX3V1, 64PM382, 9B1W3V1, 99R14V1, BD53ZQ1, 64NH382, CFR07Y1, HFL7LF1, 2NJS5V1, 451W482, H0Z7K02, 8PZRDC1, 93Z5QC1, 64PB382, EPSN0014, D1WRDC1, 1BZNPS1, 64PF382, EPSN0094, JZL6QC1, HZL6QC1, 64NK382, EPSN0153, G1YVMS1, HK8RDC1, 64NM382, EPSN0123, 2L56SD1, 9B404B1, 64NJ328, EPSN0204, 6ZNL1R1, FGTL6D1, 64PK382, EPSN0175, 1BWPS1, BZL6QC1, 144L821, EPSN0029, 2YSL6D1, 4J565D1, 9C2Y3V1, EPSN0065, 1BVLPS1, DGTL6B1, FWHJWH1, EPSN0163, 6V92BG1, 4JL7LF1, 4CDFTJ1, EPSN0048, C3Z5QC1, GZNL1R1, 8HR4W1, EPSN0190, JVM91F1, DDL7LF1, MXL8501RXX, EPSN0181, 2PG06V1, FDL7LF1, MXL93121QY, EPSN0202, CZL6QC1, CXSL6D1, MXL9364GZ8, EPSN0031, 9FF24V1, 99RW3V1, MJ03ZHJ6, EPSN0081, 2NGX5V1, 83Z5QC1, C8SQDB2, EPSN0148, D7RXFC1, 1P571F1, PBO2ECMY, EPSN0151, 2PBQ5V1, 1BTKPS1, PBO2ECLL, EPSN0221, 2PF06V1, 6R571S1, PBO2ECJD, EPSN0230, FL32VG1, 71GH6Y1, JQQC3Y2, EPSN0222, 8YJL601, 1V92BG1, 128sqw1, EPSN0134, 4982BG1, BL866T, MJ0H9AMX, EPSN0098, 2YCF701, 95BD8D1, MXL0013LL1, EPSN0001, 99W14V1, 6982BG1, MXL9414DJS, EPSN0030, 1BYNPS1, BWHJWH1, MXL0013LL5, EPSN0131, 5M32VG1, BL32VG1, 5H2SZ02, EPSN0095, CNNKLJ1, 9V92BG1, EPSN0064, AXCF701, 182Y5V1, 14VV7R1, EPSN0061, 74Y2VG1, GL32VG1, EPSN0082, 5PNKLJ1, 2NVZ5V1, EPSN0037, JVJHWH1, F2DX301, EPSN0185, HVHJWH1, F4Y2VG1, EPSN0025, 99T04V1, GYQN301, EPSN0058, FNNKLJ1, 2NTQ5V1, 7C4Y781, EPSN0133, 181V5V1, 1XHJWH1, EPSN0159, 9PNKLJ1, 2PJT5V1, BZFCP41, EPSN0023, 71PJ6Y1, 8FVSM01, 14Y3642, EPSN0195, 4QQM3K1, H982BG1, HMDSRR1, EPSN0223, 8QQM3K1, GWHJWH1, 8NNYHM1, EPSN0170, 88THVH1, DXVSM01, 23VV7R1, EPSN0092, 71YK6Y1, HL32VG1, 107712, EPSN0087, JW0QGX1, 88NLLJ1, EPSN0069, 895FVH1, 1PNJKL1, EPSN0140, 99DJVH1, 2NRR5V1, EPSN0017, G7NLLJ1, 71FK6Y1, EPSN0201, B0GKVH1, 78NLLJ1, EPSN0077, 38NLLJ1, DPNKLJ1, EPSN0021, BPNKLJ1, EPSN0207, 88RFTVH1, 71FL6Y1, EPSN0019, 9N82V21, 99RX3V1, EPSN0138, 895GVH1, J7NLLJ1, EPSN0074, 99BMVH1, 9DLX3V1, EPSN0108, DK15JL1, 999JVHW, 7FPL2V1, EPSN0034, 898GVH1, 2FSNS81, BRG311F3LJ, EPSN0129, B0CMVH1, 99CMVH1, BRJ425C90J, EPSN0141, 2TVSM01, 71HH6Y1, BRG345F06F, EPSN0149, 181X5V1, 28NLLJ1, BRJ428F1, EPSN0072, B0FKVH1, 4LPL3K1, EPSN0120, D50YWL1, 18NLLJ1, EPSN0143, 88YGVH1, 135GXR1, EPSN0166, C0RV8Y1, JW0QFX1, EPSN0176, 2RFGWL1, 88RHVH1, B69ZFN1, EPSN0144, CQQM3K1, JW0MGX1, HLWMZ02, EPSN0084, 1Z6LF41, JW0PFX1, G844RF1, EPSN0056, C5OYWL1, 13BGXR1, B844RF1, EPSN0009, 71QK6Y1, 2QQM3K1, EPSN0171, 650YWL1, GR7LF41, Service Tag - Verificar, EPSN0155, 71KK6Y1, JPQM3K1, EPSN0111, CF217T1, 1BTLPS1, EPSN0012, 6L15JL1, 99CLVH1, 7JL1ZD1, EPSN0097, CY6LF41, JKPL3K1, 6KL1ZD1, EPSN0038, 7PFGWL1, 5QRWVH1, EPSN0026, FNFGW1, 897HVH1, 7GKGD61, EPSN0006, C9L1XL1, 71XH6Y1, HLDSRR1, EPSN0112, 363PL02, 897GVH1, 1C4Y7S1, EPSN0158, 6ZQK1R1, 4T7LF41, 284Y7S1, EPSN0160, FKPQN22, 71QJ6Y1, MXL7520PNB, EPSN0127, FKXDN22, DTFGWL1, JR5002013063, EPSN0110, FL0TN22, B9L1XL1, JR5002013065, EPSN0198, FKYRN22, CFJ07Y1, 3CR33002TL, EPSN0200, FKSGN22, 363SL02, FF0477EPI, EPSN0142, FKQSN22, 34FQL02, JR5002015005, EPSN0174, FL0FN22, 353RL02, MXL5510RG2, EPSN0137, GK15JL1, 35WNL02, MXL6191BN2, EPSN0214, F88FN22, 363TL02, 1CZ1130CCK, EPSN0172, 4XXJS22, DLHMJS1, 1CZ1130CC5, EPSN0073, 4XX9S22, 13TL8Z1, MXL7411G1L, EPSN0003, 82XKS22, H13BK02, MXL6452G5N, EPSN0173, FKWSN22, 351PL02, MXL7411G4Y, EPSN0136, 834CS22, 35BQL02, MXL7191DWL, EPSN0208, 8FJJS22, 35DQL02, MXL7281VX4, EPSN0219, 831CS22, 2NWW5V1, MXL8101P8V, EPSN0154, 6ZNX1R1, CFH07Y1, MXL8501RXP, EPSN0126, 5JXJCP1, FKLFN22, MJ07PV03, EPSN0226, BD21ZQ1, FKLGN22, MXL3282GQQ, EPSN0187, 30VXKM1, FKPFN22, MXL33617HS, EPSN0211, 4172NM1, 2YF2FQ1, MXL307090F, EPSN0041, JCB2NM1, 143K8Z1, MXL5500SX0, EPSN0046, JCB1NM1, 32J0M02, MXL4491CM1, EPSN0013, FWCL581, FKQFN22, EpiFX0046, EPSN0184, JC9VKN1, F89DN22, MXL4412SFN, EPSN0224, 4151NM1, FKJGN22, MXL42608HJ, EPSN0055, 30RZKM1, FKGRN22, 4CS42602GB, EPSN0116, 30KXKM1, 8FJ8S22, MXL5500SX1, EPSN0091, 30WXKM1, 82XNS22, MXL6191BM1, EPSN0063, 753H5M1, 82YHS22, MXL61919RR, EPSN0210, 40Z0NM1, 8FHMS22, MXL61919RP, EPSN0078, 7JG1M51, 6WCLS81, MXL71513R4, EPSN0161, G5S30B1, 2PGX5V1, MXL7281VQL, EPSN0043, 2M23FQ1, 553H5M1, MXL0013LL2, EPSN0225, 9WCLS81, 9JG1M51, MXL6450XY0, EPSN0217, 5TGSCP1, 9HB2H41, JR5002017014, EPSN0188, OT7570, 4113NM1, MXL91125T6, EPSN0196, 9HG1M51, 30KXLM1, JR5002017006, EPSN0015, 48F2NM1, 550PS81, 8VZK613, EPSN0239, 5TGTCP1, 5TGRCP1, 25YSRZ2, EPSN0233, 5THHCP1, 5DSNS81, 25YQRZ2, EPSN0240, 14DL8Z1, 4173NM1, MXL9222016, EPSN0236, 71GL6Y1, 2Y71FQ1, MXL9222031, EPSN0249… Full codes in the FDA record	7,974 units (2,517 US, 5,457 OUS)
Z-0587-2025	BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988; Catalog No: 443988; UDI-DI: 00382904439880; Serial Numbers: CRP0007, CRP0025, CRP0045, CRP0064, CRP0058, CRP0060, CRP0055, CRP0040, CRP0056, CRP0038, CRP0057, CRP0062, CRP0046, CRP0031, CRP0068, CRP0053, CRP0034, CRP0041, CRP0021, CRP0054, CRP0004, CRP0001, CRP0008, CRP0009, CRP0012, CRP0013, CRP0014, CRP0017, CRP0018, CRP0048, CRP0051, CRP0027, CRP0042, CRP0069, CRP0074, CRP0032, CRP0075, CRP0077, CRP0080, CRP0079, CRP0024, CRP0011, CRP0010, CRP0016, CRP0019, CRP0028, CRP0061, CRP0063, CRP0033, CRP0044, CRP0066, CRP0067, CRP0071, CRP0043, CRP0003, CRP0026, CRP0036, CRP0050, CRP0049, CRP0070, CRP0065, CRP0059, VSP0010, CRP0052, CRP0073, CRP0072,	66 units (18 US, 48 OUS)
Z-0588-2025	BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989; Catalog No: 443989; UDI-DI: 00382904439897; Serial Numbers: CRM0001, CRM0105, CRM0114, CRM0003, CRM0113, CRM0109, CRM0010, CRM0106, CRM0108, CRM0116, CRM0117, CRM0119, CRM0004, CRM0107, CRM0112, CRM0111, CRM0115, CRM0118,	18 units (12 US, 6 OUS)
Z-0589-2025	BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990; Catalog No: 443990; UDI-DI: 00382904439903; Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207,	70 units (7 US, 63 OUS)
Z-0590-2025	BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916; Catalog No: 441916; UDI-DI: 00382904419165; Serial Numbers: CT1777, CT1168, CT1902, CT2015, CT1939, CT2084, CT2113, CT2216, CT2191, CT1972, CT1175, CT2157, CT2698, CT3324, CT1174, CT0849, CT1186, CM0122, CT2368, CT2483, CT3267, CT2423, CT2437, CT1187, CT1184, CT2405, CT2558, CT3126, CT2710, CT0838, CT2565, CT0841, CT2570, CT1203, CT2573, CT2606, CT2709, CT2670, CT2708, CT2691, CT3184, CT1753, CT2108, CT3192, CT1914, CT3173, CT3193, CT3301, CT3328, CT1316, CT3355, CT1227, CM0046, CT2478, CT1298, MX0057, CT1299, MX0059, MX0045, CT1819, CT0285, CM0041, CT1306, CT1324, CT1321, CT0137, CM0070, CT1330, CT0216, CM0064, CM0123, CT3291, CT1338, CT0171, CT0201, CT0164, CT1341, CT1346, CT0246, CT0387, 1000094, CT1642, CT1839, CT1995, CT2470, CT0971, CT0701, CT0276, CM0075, CT0296, CT0299, CT0308, CT1275, CT1682, CT1345, CT2202, CT0464, CT2496, CT0706, CT2505, CT2479, CT1348, CT0977, CT0688, CM0074, CT0340, CT1670, CT0297, CT1698, CT0920, CT2705, CT2639, CT0386, CT1684, CT0667, CT2318, CT1287, CT0422, CT2563, CM0059, CT1727, CT0468, CT1284, CT0539, CT1888, CT0457, CT0491, CT0470, CT0349, CT2101, CT2139, CT2182, CT0480, CT2193, CT2292, CT2244, CT2298, CT1361, CT0489, CT0492, CT0544, CT0500, CT1366, CT0244, CT1265, CT0513, CT0255, CT0578, CT0551, CT0559, CT1377, CT0756, CT0389, CT1381, CT0235, CT1239, CT0329, CT0644, CT0637, CT0408, CT0653, CT0675, CR1423A, CT0434, CT0573, CT0577, CT0295, CT0707, CT0619, CT0203, CT0553, CT0447, CT0448, CT0459, CT0516, CT1687, CT1691, CT1695, CT1710, CT1653, CT1701, CT1709, CT1694, CT1707, CT0725, CT0732, CT0757, CT1723, CT2477, CT1731, CT1730, CT1728, CT1732, CT0546, CT0497, CT0521, CT0784, CT0684, CT0792, CT1283, CT1252, CT1102, CT0864, CT0836, CT0865, CT1144, CT0944, CT1154, CT1147, CT1429, MX0033, CT1327, 1000100, CT1404, CT1413, CT1417, CT1457, CM0106, CT1719, CT0877, CT1761, CT1434, CT1787, CT1801, CT1817, CT1832, CT1559, CT1430, CT1843, CT1868, CT1586, CT1892, CT1436, CT1882, CT1441, CT1783, CT1791, CT1804, CT1638, CT0900, CT0906, CT1651, CT1655, CT0595, CT1453, CT1464, CT1669, CT1649, CT1881, CT0946, CT2607, CT1955, CT2649, CT2031, CT2110, CT1947, CT2133, CT2468, CT2020, CT1017, CT2009, CT2029, CT2064, CT0962, CT2066, CT0902, CT2060, CT2071, CT2074, CT2099, CT2097, CT2121, CT0963, CT2137, CT2138, CT2140, CT1458, CT1466, CT2159, MX0035, CT0937, MX0037, CT2197, CT2205, CT2200, CT0217, CT0269, CT2201, CT1334, CT2208, CT2209, MX0008, CT2217, CT2235, CT2225, CT3066, CT2227, EP0003, CT2435, CT0478, CT2259, CT2260, CT0496, CT0495, CT1474, CT2267, CT2280, MX0028, CT2285, CT1483, CT2286, CT2297, CT2281, CT0967, CT0547, CT3182, MX0053, CT2327, CM0030, CT0998, CT0174, CT2369, CT1588, CT0839, CT1484, CT0991, CT0885, CT0887, CT1025, CT1027, CT1493, CT0749, CT1490, CT0845, CT1501, CT2596, CT2595, CT1505, CT0907, CT1050, CT1507, CT1051, CT1056, CT1043, CT1075, CT0936, CT1514, CT1076, CT1518, CT1018, CT1039, CT1082, CT0617, CM0045, CT1526, CT2658, CT1509, CT3138, CT3181, CT0883, CT2367, CT1530, CT1218, CT3244, CT2329, CT0605, CT2373, CT0169, CT0636, CT3297, CT2577, CT1499, CT0641, CT0600, CT0483, CT0183, CT3304, CT1487, CT1529, CT3358, CT1535, CT0527, CT1536, CT1676, CT1084, CT1540, CT1824, CT0555, CT0383, CT2439, CT0381, CT1028, CT2392, CT0550, CT2490, CT2537, CT0598, CT1312, CT1562, CT2519, CT0482, CT1760, CT0582, CT1890, CT1952, CT2023, CT2549, CT1574, CT1570, CT0585, CT1549, CT1573, CT1578, CT2640, CT3030, CT0905, CT3034, CT0897, CT1599, CT0157, CT1605, CT0462, CT2576, CT0608, CT1593, CM0036, CM0098, CT0413 , CM0069, CT2680, CT1596, CT2676, CT1601, CT1597, CT1614, CT1622, CT2580, CT0940, CT0733, CT1623, CT0669, CT0736, CT0771, CT0728, CT2328, CT1621, 1000085, CT3136, CT3142, CT1720, CT1740, CT1752, CT1758, CT1755, CT0303, CT1737, CT1773, CT1782, CT1784, CT1772, CT1217, CT1788, CT0955, CT1815, CT3018, CT3026, CT1809, CT3075, CT1823, CT1825, CT1812, CT1822, CT1838, CT1829, CT3038, CT0257, CT2501, CT3027, CT2380, CT0709, CT1830, CT0835, CT1854, CT1852, CT1863, CT1867, CT1885, CT1880, CT0221, CT2643, CT1897, CT1895, 1000013, CT2411, CT2445, CT1922, CT1932, CT1071, CR0005, CT2462, CT2467, CT2642, CT2487, CT2489, CT1650, CT1648, CT0786, CT1661, CT1663, CT1658, CT1683, CT1678, CT1688, CT2506, CT1966, CT1964, CT1958, CT2511, CT1943, CT1950, CT1962, CT1981, CT1986, CT1980, CT1983, CT1959, CT1280, CT1976, CT0363, CT1992, CT1991, CT2003, CT0789, CT3177, CT3119, CT0670, CT0931, CT0979, CT0713, CT0785, CT1363, CT2007, CT2481, CT1572, CT2011, CT2019, CT0765, CT3183, CT2018, CT2024, CT3028, CT2032, CT3029, CT2021, CT1879, CT2040, CT2054, CT2050, CT2044, CT2065, CT2063, CT2090, CT2282, CT0668, CT2098, CT2107, CT2083, CT2105, CT2106, CT2111, CT2120, CT0930, CM0013, CT2152, CT3044, CT2136, CT1402, CT2166, CT0507, CT2180, CT2164, CT2199, CT0359, CT0168, CT0266, CT2169, CT2196, CT2184, CT0353, CT0316, CT2162, CT0479, CT0494, CT3223, CT0591, CT0524, CT0549, CT0181, CT2228, CT0708, CT2222, CT2239, CT0335, CT0564, CT0518, CM0113, CT2238, CT2254, CT2258, CT0493, CT2263, CT2256, CT2266, CT0632, CT3204, CT0862, CT2274, CT3337, CT2277, CT0485, CT0860, CT2291, CT2293, CT0928, CT2251, CT2288, CT2303, CT3217, CT3219, CT2312, CT2272, CT2325, CT2320, CT2287, CT2334, CT2348, CT2355, CT2356, CT3293, CT3352, CT3353, CT3331, CT2655, CT0914, CT0916, CT0919, CT1686, CT1715, CT2344, CT1347, CT1336, CT1476, CT1757, CT1774, CT1901, CT1899, CT0715, CT0173, CT3307, CT3308, CT2158, CT2131, CT1127, CT2316, CT1492, CT2290, CT0176, CT0394, CT1741, CT0393, CT1785, CT0402, CT1803, CT1903, CT2004, CT2096, CT2220, CM0126, CT2407, CT2440, CT2469, CT2482, CM0034, CT2474, CT2476, CT2525, CM0039, CT2491, CT0240, CT2428, CT2550, CT2568, CT2586, CT0487, CT2591, CT2581, CT2588, CT2602, CT2589, CT1319, CT0794, CT2465, CT2399, CT3004, CT3310, CT0163, CT2370, CT2535, CT3340, CM0043, CT3294, CT0634, CT3336, CT0191, CT0908, CT3367, CT3313, CT3315, CT3332, CM0067, CT0209, CT1929, CT1181, CT0197, CT0770, CT0210, CT1553, CT0741, CT1471, CT2598, CT2008, CT1800, CT1870, CT1927, CT1951, CT0758, CT0735, CT0798, CT0761, CM0124, CT0825, CM0092, CT1926, CT0952, CT3019, CT0949, CT0938, CT0960, CT3289, CT0159, CT0965, CT0961, CM0102, CT0156, CT2231, CT0140, CT1049, CM0128, CT1865, CT0611, CT0612, CT2061, CT0167, CT2406, CT0740, CR0009, CT0993, CT2522, CT1030, CM0119, CT2304, CT1006, CT1004, CT1011, CT1008, CT3250, CT3252, CT3286, CT3211, CM0130, CR0003, CT3256, CT1180, CT1662, CT1035, CT0247, CT0248, CT1046, CT1141, CT1128, CT1093, CT1059, CT1314, MX0062, CT0319, CM0093, CM0026, CT1063, CT1365, CT0219, CT0268, CT0442, CT1713, MX0030, MX0032, CT0987, CT0256, CT1081, CT1079, CT1232, CT0325, CT1150, CT0592, CT1449, CT1125, CT1506, CT1087, CR0008, CT0231, CT1556, CT3091, CT1119, CT3040, CT1598, CT2612, CT2500, CT2674, CT2677, CT2371, CT2682, CT1736, CT2694, CT3068, CT3084, CT3090, CT1759, CT3097, CT1805, CT3098, CT2616, CT2617, CT1876, CT1094, CT3061, CT3063, CT1092, CT1189, CT1644, CT3106, CT3115, CT1367, CT3116, CT3067, CT3079, CT3081, CT1101, CT2695, CT2706, CT3135, CT1664, CT3120, CT1419, CT3131, CT3153, CT2135, CT1104, CT3145, CT3143, CT0259, CT1111, CT2223, CT1113, CT1527, CT3228, CT3231, CT3236, CT3154, CT3157, CT3168, CT3159, CT3124, CT3174, CT0373, CT3180, CT2306, CT3198, CT3218, CT3203, CT3213, CT3214, CT2379, CT1747, CT1750, CT1915, CT2360, CT0284, CT1212, CT1636, CT1996, CT2058, CT2153, CT2190, CT1215, CT1230, CT1247, CT0304, CT0281, CT0800, CT2641, CT2635, CT1251, CT2650, CT0370, CT1065, CT0144, CT0368, CT2683, CT2644, CT0406, CT0719, CT2654, CT0344, CT0358, CT0629, CT0661, CT2396, CT1383, CT2352, CT1368, CT0909, CT0290, CT2409, CT0313, CT0314, MX0015, CT0361, CT0934, CT0975, CT0750, CM0040, CT2486, CM0048, CT2509, CT1085, CT2295, CT0981, CT2497, CT2438, CT1086, CT0672, CT1340, CT2508, CT1177, CT1036, CT2473, CT2335, CT2397, CT0543, CT2495, CT2503, CT2533, CT1254, CT1258 no4/4, CT1009, CT2536, CT0405, CT1329, CT2603, CT2626, CT2567, CT0808, CT2560, CT0829, CT3031, CT0833, CT2571, CT2574, CT0899, CT2579, CT1358, CT1355, CT0995, CT1029, CT1398, CT2590, CT1408, CT1222, CT1394, CT0236, CT2502, CT2593, CT2614, CT1356, CT1667, CT1671, CT1685, CT2601, CT1700, CT1697, CT1696, CT2631, CT1176, CT2613, CT2620, CT0412, CT3125, CT3117, CT1411, CT3137, CT3037, CT3164, CT3036, CT3139, CT1418, CT3150, CT3152, CT1435, CT3158, CT1442, CT1446, CT1451, CT1440, CT1452, CT1443, CT1461, CT1444, CT1468, CT3148, CT1463, CT3170, CT3155, CT1450, CT1459, CT0910, CT3272, CT3265, CT3253, CT3259, CT3254, CT1244, CT3276, CT3266, CT3260, CT1248, CT3263, CT3273, CT3277, CT3279, CT1403, CT1498, CT1250, CT1339, CT0432, CT0431, CT1362, CT3024, CT1523, CT0716, CT0958, CT1010, CT1517, CT0437, CT3022, CT3025, CT1256, 1000053, CT3047, 1000063, 1000088, CT3050, CT1528, CT3035, CT3033, CT1331, CT0439, CT1255, CT3052, CT3053, CT0554, CT1260, CT1259, CT1263, CT1497, CT1566, CT0418, CT3051, CT3054, CT3056, CT3055, CT1264, CT1455, CT0430, CT1569, CT3069, CT3076, CT1583, CT1594, CT1281, CT1478, CT3095, CT1613, CT1702, CT3088, CT2336, CM0066, CT2353, CT1188, CT3111, CT1999, CT2669, CT2692, CT1224, CT2688, CT2030, CT2653, CT1712, CT1718, CT1291, CT1726, CT1739, CT2181, CT1762, CT1294, CT0645, CT1763, CT1795, CT2174, CT2246, CT1790, CT2645, CT2656, CT1089, CT1173, CT1537, CT2308, CT0643, CT1328, CT0642, CT2685, CT1859, CT1860, CT1831, CT2697, CT1875, CT1117, CT1122, CT2700, CT1891, CT1889, CT1900, CT1400, CT0520, CT0522, CT1431, CR0941, CT0811, CT1409, CT1133, CT3006, CT1152, CT3002, CT1925, CT1923, CT1546, CT1930, CT3001, CT1155, CT1545, CT1933, CT1157, CT1931, CT1984, CT1160, CT1985, CT3008, CT3012, CT2002, CT0540, CT3163, CT1779, CT2012, CT1872, CT1542, CT2037, CT1602, CT1589, CT1311, CT1582, CT1603, CT0674, CT3172, CT1834, CT1313, CT1308, CT1918, CT2059, CT2041, CT1317, CT1610, CT2053, CT2067, CT2072, CT2109, CT3232, CT1619, CT2073, CT1628, CT2123, CT2118, CT2351, CT2151, CT2124, CT1743, CT1744, CT0978, CT1746, CT2129, CT2207, CT1396, CT3151, CT2241, CT2249, CT2257, CT1794, CM0116, CT1806, CT2252, CT1828, CT2265, CT0696, CT0138, CT0685, CT2294, CT2302, CT3270, CT1850, CT0697, CT0700, CT3275, CT3278, CT1869, CT1906, CT1624, CT1633, CT1627, CT3280, CT1635, CT2361, CT0712, CT1164, CT1166, CM0121, CT3314, CT3321, CT3269, CT0830, CT0831, CT3205, CT3216, CT3224, CT3220, CT3366, CT2091, CM0079, CT0923, CT3384, CT3377, CT0092, CT3376, CT3381, CT1322, CT3399, CT3396, CT3401, CR0007, CT1873, CT2149, CT1609, CT1617, CT1631, CT1629, CT1392, CT2417, CT0844, CT1708, CT2426, CT2430, CT2443, CT0548, CT0536, CT2538, CT2518, CT2463, CT2466, CT2459, CT2460, CT2456, CT2203, CT3187, CT1372, CT2422, CT0959, CT1207, CT1211, CT1190, CT1146, CT1221, CT1220, CT1236, CT1229, CT1064, CT1539, CT1040, CT1276, CT1604, CT1606, CT1580, CT1607, CT1608, CT1611, CT1387, CT1382, CT2359, CT1738, CT1100, CT2188, CT0985, CT1158, CT1261, CT1241, CT1904, CT1907, CT1883, CT1300, CT3245, CT3264, CT3268, CT3274, CT3258, CT1332, CT1318, CT0237, CT0436, CT1405, CT1674, CT1921, CT1659, CT1693, CT1679, CT2527, CT1421, CT1414, CT1406, CT1437, CT2043, CT1472, CT1467, CT1469, CT1448, CT1425, CT1015, CT3248, CT1668, CT1460, CT1473, CT2331, CT1826, CT1109, CT1223, CT2609, CT3015, CT3102, CT3326, CT3247, CT1161, CT1558, CT2183, CT1590, CT1407, CT1438, CT1778, CT1584, CT1454, CT1486, CT1488, CT2242, CT1538, CT2521, CT1543, CT1581, CT1591, CT1585, CT1612, CT1748, CT1797, CT3014, CT2324, CT1544, CT1840, CT1706, CT2323, CT2340, CT1625, CT1632, CT1630, CT2170, CT1742, CT1764, CT1765, CT2383, CT1768, CM0072, CT1771, CT1789, CT2343, CT1827, CT2233, CT2314, CT2416, CT2382, CT2427, CT2420, CT1861, CT2425, CT1877, CT1857, CT2434, CT1836, CT2561, CT2529, CT1887, CT3078, CT1833, CT2450, CT3092, CT3109, CT3086, CT2472, CT2161, CT2400, CT2432, CT2678, CM0087, CT2711, CT3000, CT3074, CT3073, CT1641, CT1652, CT1654, CT1935, CT2679, CT3188, CT1937, CT1898, CT1945, CT3195, CT3199, CT1946, CT1934, CT1940, CT1990, CT1997, CT3190, CT2010, CT2026, CT3309, CT2042, CT2027, CT2049, CT2048, CT0534, CT0278, CT2419, CT2094, CT2095, CT1424, CT2147, CT2150, CT2171… Full codes in the FDA record	2,537 units (876 US, 1,661 OUS)
Z-0591-2025	BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150; Catalog No: 444150; UDI-DI: 00382904441500; Serial Numbers: JRPN215003AB, BTDN93800189, JRPN215003VS, BTDN938000WP, BTDN938000XZ, BTDN93600B4R, BTDN0160058Z, BTDN939007WP, BTDN938000Z3, BTDN940003G5, BTDN932008FF, BTDN94000424, BTDN940003AV, BTDN938000WY, JRPN215003UA, JRPN215003M8, BTDN01800017, JRPN215003V7, BTDN934008WP, JRPN215003M4, BTDN939007Z9, JRPN2150038H, BTDN9380016F, BTDN938000WU, BTDN938001FL, JRPN215004L1, BTDN93600B0K, JRPN215003E8, BTDN934008S2, BTDN93600B3E, JRPN215004R7, JRPN215003CL, BTDN93600B5G, BTDN9200040Q, JRPN215004J9, JRPN21500418, BTDN934008UD, BTDN920003X8, JRPN215003JT, BTDN0180005Q, JRPN215003CZ, BTDN018000DT, JRPN215003CR, BTDN934008T2, JRPN215003M1, JRPN215003HR, JRPN215003TN, BTDN934008CE, BTDN932009P7, JRPN215003JG, JRPN215003X3, BTDN926003PU, BTDN928007ZA, BTDN926003UW, BTDN933008XS, BTDN9380014T,	56 units (OUS only)
Z-0592-2025	BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624; Catalog No: 443624; UDI-DI:00382904436247; Serial Numbers: PF4176, PF4182, PF2302, PF4198, PF4149, PF4189, PF4202, PF2699, PF4200, PF4207, PF4209, PF2704, PF2640, PF2769, PF3383, PF2742, PF5292, PF4215, PF4204, PF0571, PF4188, PF4216, PF1642, PF4231, PF0929, PF4240, PF3443, PF0934, PF4232, PF4212, PF0566, PF3126, PF5408, PF5436, PF1716, PF5384, PF5396, PF5398, PF5404, PF3345, PF5443, PF3203, PF3128, PF0598, PF3447, PF0601, PF5489, PF5495, PF5022, PF5063, PF3362, PF3340, PF5459, PF5492, PF5462, PF5499, PF0703, PF5466, PF0880, PF0705, PF5525, PF5469, PF5471, PF3397, PF4309, PF4397, PF5547, PF0632, PF0638, PF4443, PF0637, PF5200, PF5549, PF5202, PF5550, PF0643, PF5049, PF0639, PF3204, PF5207, PF5094, PF5209, PF5117, PF1352, PF5217, PF5148, PF5231, PF5195, PF5097, PF5162, PF5109, PF5169, PF5179, PF5183, PF2063, PF5197, PF5203, PF5168, PF5323, PF5329, PF0687, PF5352, PF5353, PF5418, PF5350, PF2796, PF5359, PF5227, PF3169, PF5351, PF5365, PF5218, PF5361, PF5389, PF5265, PF5266, PF5328, PF5337, PF2274, PF0707, PF6126, PF0718, PF5356, PF5403, PF6167, PF5027, PF5349, PF5371, PF6174, PF4049, PF4071, PF4444, PF4064, PF4292, PF4305, PF4306, PF4315, PF4317, PF5042, PF4285, PF4287, PF4304, PF4373, PF4376, PF4407, PF4297, PF5043, PF4294, PF5072, PF5082, PF4251, PF4254, PF4393, PF4394, PF1032, PF5140, PF4252, PF5143, PF4253, PF5144, PF4335, PF4379, PF4390, PF4419, PF4308, PF5414, PF4295, PF5431, PF4337, PF4100, PF4415, PF4420, PF1054, PF2590, PF4346, PF5633, PF4278, PF4439, PF5874, PF5877, PF4338, PF4436, PF4430, PF5887, PF5011, PF5024, PF5048, PF5790, PF1478, PF1483, PF5047, PF4406, PF5134, PF1932, PF5021, PF5947, PF5029, PF5050, PF5130, PF5142, PF5145, PF5156, PF4412, PF1481, PF1091, PF5125, PF1096, PF5129, PF1099, PF5135, PF5088, PF1154, PF5108, PF1305, PF5164, PF6098, PF5111, PF1298, PF1373, PF1387, PF5153, PF6304, PF1477, PF6305, PF1513, PF6307, PF1743, PF5058, PF5064, PF5087, PF5078, PF0575, PF0534, PF0828, PF0928, PF5013, PF0672, PF0673, PF0675, PF1969, PF0429, PF1497, PF0533, PF2269, PF0633, PF5051, PF0841, PF1011, PF0719, PF0721, PF0737, PF0758, PF5107, PF5275, PF5493, PF5518, PF5163, PF0306, PF5472, PF0409, PF5494, PF5508, PF5509, PF5517, PF5521, PF0463, PF5522, PF2316, PF5527, PF2299, PF1124, PF0468, PF2407, PF0515, PF0628, PF0630, PF5582, PF0626, PF0879, PF0677, PF1112, PF5257, PF0541, PF0794, PF1122, PF1119, PF5548, PF1001, PF5555, PF0984, PF5561, PF5571, PF5572, PF5575, PF5589, PF5591, PF2200, PF5594, PF2202, PF5598, PF2096, PF5599, PF0004, PF1569, PF1045, PF1662, PF1405, PF1641, PF1412, PF1414, PF2003, PF2132, PF2223, PF2324, PF1528, PF1147, PF2369, PF2653, PF2561, PF5608, PF5611, PF2697, PF2268, PF1153, PF2546, PF0197, PF0199, PF0268, PF5733, PF5270, PF4099, PF4172, PF5613, PF0493, PF0494, PF0496, PF5957, PF1196, PF5966, PF1189, PF1195, PF1188, PF1192, PF0082, PF1202, PF0085, PF1201, PF1207, PF1206, PF1214, PF1191, PF1229, PF1230, PF1231, PF0614, PF0275, PF0190, PF0273, PF1257, PF1262, PF1063, PF1062, PF2379, PF0792, PF1208, PF0938, PF0942, PF1376, PF1384, PF1386, PF1390, PF0097, PF0094, PF0096, PF1408, PF0165, PF1285, PF0214, PF2360, PF2068, PF0307, PF2393, PF4056, PF2406, PF4017, PF3368, PF3197, PF3059, PF1354, PF1410, PF2564, PF1425, PF5173, PF5254, PF3412, PF4238, PF1430, PF1432, PF4384, PF1434, PF4223, PF4222, PF1417, PF0612, PF1422, PF1396, PF5832, PF0065, PF5833, PF0071, PF5862, PF5869, PF5822, PF0264, PF5825, PF3147, PF1507, PF5829, PF1423, PF5821, PF1427, PF5818, PF5830, PF5860, PF5861, PF1452, PF1437, PF0232, PF5693, PF1436, PF5682, PF2480, PF1508, PF1517, PF0751, PF1566, PF1720, PF6189, PF6171, PF6243, PF6254, PF6175, PF5240, PF2426, PF1582, PF2306, PF0319, PF0322, PF4325, PF1626, PF5480, PF1627, PF1752, PF1748, PF0917, PF1527, PF1531, PF0318, PF1816, PF0892, PF1537, PF1309, PF1539, PF0205, PF1371, PF1450, PF1451, PF1791, PF2236, PF2130, PF0013, PF2374, PF0023, PF0025, PF0028, PF0038, PF1591, PF1951, PF0034, PF1607, PF2752, PF1603, PF2760, PF0049, PF0054, PF4195, PF1630, PF1631, PF2975, PF3253, PF4068, PF5302, PF5320, PF0105, PF0102, PF1634, PF1637, PF1644, PF1648, PF1654, PF0600, PF1651, PF2330, PF2355, PF1669, PF2357, PF1673, PF1676, PF4367, PF2521, PF2836, PF2840, PF0144, PF5800, PF5791, PF5855, PF1677, PF5560, PF0150, PF0156, PF1686, PF1692, PF6086, PF6102, PF2839, PF1703, PF6112, PF1700, PF6124, PF6375, PF6125, PF6377, PF1116, PF1727, PF3172, PF1744, PF0290, PF0250, PF0181, PF4076, PF0233, PF0298, PF0296, PF0297, PF0291, PF1756, PF1758, PF0325, PF4326, PF1759, PF4371, PF0342, PF1772, PF0327, PF5005, PF0332, PF0234, PF0358, PF0349, PF0352, PF0086, PF0513, PF0615, PF0015, PF1820, PF1823, PF0570, PF0108, PF0572, PF0716, PF0712, PF0739, PF0717, PF0262, PF0823, PF4063, PF0263, PF0762, PF1830, PF1140, PF1832, PF0328, PF1824, PF0982, PF1827, PF0338, PF1169, PF1006, PF0532, PF1536, PF1554, PF0497, PF1277, PF1870, PF1965, PF1967, PF3050, PF2116, PF2083, PF0564, PF2503, PF0500, PF2502, PF2501, PF2213, PF2588, PF2087, PF2662, PF2782, PF2732, PF2992, PF2953, PF3010, PF1876, PF2206, PF1890, PF1247, PF1891, PF0839, PF4171, PF4184, PF3365, PF5243, PF2084, PF5189, PF5605, PF6333, PF0586, PF2477, PF4058, PF4055, PF2580, PF4083, PF1962, PF0884, PF1002, PF1003, PF0427, PF3225, PF3235, PF3341, PF3389, PF3411, PF1524, PF1995, PF2004, PF1583, PF2201, PF1624, PF1576, PF4429, PF1593, PF1279, PF1818, PF1834, PF2023, PF2025, PF5286, PF5069, PF2358, PF2422, PF2423, PF2036, PF5276, PF5290, PF5343, PF2219, PF2530, PF2651, PF2055, PF4400, PF2513, PF2054, PF2056, PF2965, PF2960, PF3112, PF3111, PF2067, PF5445, PF5648, PF4225, PF5958, PF6008, PF6054, PF6327, PF6329, PF1149, PF2088, PF2090, PF0041, PF2135, PF1990, PF2126, PF0053, PF4226, PF0017, PF0201, PF0415, PF0253, PF0426, PF5256, PF5261, PF0526, PF0972, PF0989, PF0217, PF0213, PF0593, PF0676, PF0971, PF2301, PF1084, PF1218, PF1616, PF1086, PF1113, PF1222, PF1379, PF1482, PF1485, PF0072, PF3145, PF1615, PF0073, PF2701, PF1707, PF1710, PF1740, PF2541, PF1859, PF1927, PF2108, PF3317, PF0110, PF3322, PF0109, PF4075, PF4134, PF0837, PF0908, PF1415, PF5229, PF0069, PF5255, PF0635, PF5333, PF5330, PF2419, PF5773, PF5798, PF0106, PF4284, PF2347, PF2346, PF2819, PF3217, PF3231, PF2566, PF0188, PF5003, PF5687, PF0414, PF0416, PF4051, PF1211, PF1180, PF1210, PF1263, PF3326, PF1133, PF1178, PF3339, PF4095, PF4266, PF4279, PF2844, PF2978, PF1266, PF3008, PF2519, PF3063, PF2523, PF2499, PF2242, PF2239, PF3200, PF3271, PF3269, PF3066, PF3085, PF3353, PF3355, PF3178, PF3400, PF4002, PF3404, PF3212, PF3379, PF3440, PF3376, PF3406, PF5215, PF5192, PF4291, PF4094, PF3301, PF5380, PF3331, PF5260, PF5464, PF0050, PF0435, PF0436, PF2643, PF1121, PF0499, PF0581, PF2676, PF5538, PF0588, PF4343, PF0649, PF0650, PF0870, PF0005, PF0103, PF0967, PF1223, PF2221, PF2217, PF1976, PF1982, PF1991, PF2712, PF1938, PF1999, PF3133, PF5190, PF3138, PF3137, PF2218, PF2456, PF2483, PF2485, PF2490, PF2557, PF2190, PF2761, PF2138, PF2142, PF2531, PF2549, PF2559, PF2558, PF2654, PF3020, PF2981, PF2993, PF2790, PF3021, PF4319, PF2831, PF5334, PF0743, PF5310, PF1600, PF2854, PF5744, PF5315, PF2930, PF2932, PF3388, PF5379, PF5568, PF3205, PF0787, PF2894, PF2925, PF2964, PF5732, PF1454, PF3006, PF3009, PF5916, PF5689, PF5949, PF5965, PF5978, PF3030, PF6313, PF6310, PF3034, PF5979, PF5039, PF0080, PF3067, PF0089, PF3079, PF0182, PF3099, PF6042, PF3118, PF3119, PF3121, PF5461, PF6285, PF3262, PF3264, PF6287, PF6308, PF5845, PF3405, PF5680, PF5788, PF6136, PF6312, PF6314, PF4005, PF4065, PF6148, PF4061, PF4164, PF6317, PF4169, PF6081, PF4130, PF4138, PF5222, PF3174, PF5223, PF6160, PF4136, PF3176, PF4137, PF4048, PF5988, PF5990, PF4424, PF5991, PF5992, PF5635, PF5554, PF1368, PF5781, PF6351, PF5763, PF6355, PF5782, PF6358, PF6396, PF1584, PF0722, PF0754, PF1131, PF2044, PF1959, PF0461, PF5900, PF5902, PF5905, PF5908, PF5896, PF1135, PF1136, PF6082, PF6083, PF6077, PF6115, PF6116, PF1535, PF1017, PF1601, PF0584, PF0453, PF0518, PF0523, PF0756, PF1221, PF2433, PF2452, PF2416, PF1855, PF2165, PF2707, PF3096, PF2555, PF2744, PF2794, PF3414, PF4022, PF0101, PF0257, PF6139, PF3309, PF3316, PF6079, PF0218, PF4237, PF0237, PF0379, PF4259, PF4112, PF4177, PF4183, PF3346, PF0951, PF0958, PF1098, PF0953, PF4243, PF0994, PF0896, PF1171, PF5628, PF5592, PF6217, PF6235, PF6220, PF2100, PF5623, PF1894, PF1895, PF6258, PF1893, PF1097, PF1355, PF1360, PF0714, PF5852, PF5884, PF1488, PF1493, PF5704, PF5692, PF5722, PF5724, PF5597, PF1663, PF5729, PF1658, PF1650, PF0035, PF5752, PF5726, PF5759, PF0747, PF0753, PF1653, PF1655, PF5967, PF1804, PF1879, PF1961, PF1118, PF1950, PF1948, PF6147, PF0450, PF0587, PF6242, PF1892, PF1960, PF1761, PF6173, PF1469, PF1132, PF1973, PF4128, PF1964, PF2338, PF2339, PF2337, PF2365, PF0948, PF2434, PF2192, PF2349, PF2332, PF2686, PF2127, PF2125, PF0411, PF0704, PF0044, PF2612, PF2571, PF0465, PF2678, PF4409, PF2788, PF0193, PF2874, PF2871, PF2867, PF0194, PF0195, PF0725, PF0278, PF0281, PF4217, PF0819, PF0820, PF0821, PF3393, PF0752, PF0965, PF0913, PF0916, PF0956, PF4057, PF0061, PF0961, PF0063, PF5539, PF1532, PF1561, PF1595, PF5883, PF5669, PF5939, PF0083, PF0088, PF5981, PF3051, PF5984, PF6015, PF6058, PF2154, PF6052, PF6151, PF3017, PF3036, PF3047, PF3041, PF3044, PF3080, PF6131, PF3082, PF3088, PF3089, PF3091, PF6341, PF6342, PF6360, PF6362, PF0037, PF0293, PF2071, PF1562, PF1599, PF0135, PF1904, PF0198, PF0200, PF0372, PF3065, PF2472, PF3144, PF3153, PF0390, PF2066, PF2661, PF2656, PF2719, PF2734, PF2745, PF0698, PF2747, PF2748, PF2750, PF3154, PF3155, PF3157, PF0256, PF3236, PF0128, PF0187, PF2998, PF3416, PF0191, PF0174, PF0930, PF0227, PF5154, PF0230, PF0822, PF0231, PF0825, PF0238, PF0240, PF0239, PF0946, PF0392, PF0926, PF2989, PF1038, PF1040, PF1069, PF4151, PF4160, PF1070, PF1078, PF1237, PF1000, PF0597, PF5668, PF5663, PF0599, PF4006, PF0610, PF5716, PF3395, PF4380, PF4328, PF4044, PF1013, PF4039, PF4021, PF1255, PF4111, PF4106, PF0366, PF5878, PF5390, PF0619, PF1148, PF4323, PF0172, PF5933, PF5347, PF0167, PF6093, PF6120, PF6158, PF0621, PF1143, PF1251, PF5348, PF5714, PF5808, PF0921, PF0177, PF5804, PF0179, PF5812, PF5851, PF5848, PF5449, PF5490, PF0178, PF5746, PF5926, PF0421, PF5952, PF5971, PF5931, PF1248, PF6200, PF1246, PF6067, PF5976, PF6237, PF1573, PF1367, PF6331, PF0196, PF1505, PF0368, PF0370, PF1287, PF6068, PF1139, PF0886, PF0849, PF2174, PF1224, PF6198, PF1253, PF1471, PF0803, PF1335, PF1233, PF0299, PF6201, PF1668, PF1467, PF1945, PF0812, PF1812, PF1519, PF0817, PF1321, PF2980, PF0689, PF2600, PF1344, PF1526, PF1777, PF0247, PF1781, PF0357, PF1708, PF0160, PF1810, PF0170, PF1019, PF0265, PF1782, PF0447, PF0445, PF1709, PF0361, PF1861, PF0446, PF1041, PF0729, PF0180, PF0858, PF4052, PF1864, PF0668, PF3303, PF4024, PF0749, PF2395, PF1714, PF2079, PF4185, PF2030, PF5793, PF0100, PF0944, PF0726, PF0693, PF0301, PF0099, PF2114, PF2051, PF2078, PF2412, PF2111, PF0833, PF0398, PF2131, PF0404, PF0403, PF2110, PF0462, PF2112, PF1786, PF0478, PF0483, PF0475, PF1887, PF0346, PF1954, PF0348, PF2298, PF0228, PF2210, PF2031, PF0551, PF0553, PF0356, PF0544, PF0546, PF0547, PF2304, PF2070, PF2294, PF0224, PF0552, PF0556, PF0624, PF2335, PF0376, PF0987, PF2404, PF2195, PF1993, PF2046, PF2058, PF2540, PF2297, PF2869, PF4173, PF0397, PF0400, PF2879, PF2043, PF2918, PF3256, PF3258, PF2027, PF3252, PF2408, PF3104, PF3148, PF3246, PF3275, PF2553, PF0640, PF0659, PF3284, PF0730, PF3116, PF0731, PF2535, PF3115, PF3242, PF3290, PF3328, PF2920, PF3306, PF0831, PF2148, PF3114, PF4113, PF3278, PF0750, PF3324, PF3367, PF4398, PF4418, PF0408, PF3239, PF0442, PF0460, PF3319, PF3310, PF3369, PF4318, PF4413, PF5038, PF5123, PF3366, PF3370, PF3372, PF1134, PF0070, PF3386, PF3387, PF0051, PF0087, PF0448, PF5238, PF5285, PF0505, PF0134, PF0137, PF5289, PF3216, PF0594, PF0670, PF4387, PF0340, PF4351, PF3429, PF5297, PF5287, PF4178, PF4093, PF5679, PF0888, PF5805, PF0850, PF0871, PF0922, PF1056, PF0846, PF0851, PF1034, PF1026, PF2950, PF3109, PF4042, PF5847, PF0890, PF0891… Full codes in the FDA record	4,411 units (567 US, 3,844 OUS)
Z-0593-2025	BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385; Catalog No: 441385; UDI-DI: 00382904413859; Serial Numbers: FT9750, FT8660, FT9839, FT5241, FT9840, FT9841, T10574, FT5251, FT9796, FT1325, FT9880, FT9881, T10575, FT9884, FT7169, FT7177, T10563, T10519, FT9734, FT7161, FT7181, T10536, FT7756, FT0538, FT8653, T10008, FT7203, FT7197, FT7714, T10821, FT7192, FT7201, T10037, T10042, T10817, T10615, T10629, T10746, T12324, T10716, FT7215, T10011, FT7222, T10834, T12452, T12455, FT7204, T10845, FT7209, T10945, FT5382, FT0043, T10758, FT0055, T10589, FT0071, T10289, T10293, T12380, T10547, FT0059, T10550, FT0106, T12372, FT0110, FT7232, FT7680, FT7220, FT0116, FT0084, FT7211, FT7480, FT7489, FT0120, FT7219, T10836, T10683, FT7213, T10791, FT7245, T12357, FT7504, FT7619, T12511, FT7675, FT0282, FT7679, T12379, FT7715, FT7246, T12195, T12442, T11036, T12215, FT0383, T12200, T12418, T12212, FT7256, FT0373, FT5317, FT0341, T12202, FT0615, T12294, T12209, T12308, FT5261, FT7978, T12206, T12482, FT5263, T12213, FT7270, T12229, FT0384, FT0385, FT5266, T12128, T12233, FT0436, FT0666, FT0671, FT7281, FT0560, T12003, FT7276, T12225, FT0118, FT5386, FT5388, FT0434, FT7307, FT5389, FT0374, T12205, FT0519, T12134, FT7303, T12222, FT0521, T12646, T12226, T12228, FT0007, T12789, T12254, T12234, FT7311, FT0500, T12885, T12124, FT0414, FT0631, T12901, FT0894, T12615, T12232, FT0966, FT0659, T12637, FT0437, FT7358, T12259, FT0785, FT7366, FT0748, T12498, T12325, T13006, FT7360, FT0784, FT0808, T13184, FT0799, FT3882, T13182, T12349, FT5429, T20193, FT0653, T20198, FT7380, T12327, FT0951, T12456, FT0893, FT0881, T10797, FT0701, T20230, FT2230, FT7390, T12047, FT0923, T20232, FT0878, T20300, FT0921, T12048, FT1022, T12046, T10963, T10957, T10695, T10798, FT1303, FT5141, FT1177, T10691, FT4841, T10696, FT1219, T10702, FT1053, T10728, FT0996, FT7785, FT1711, FT1069, FT7787, FT7788, FT3603, FT1714, FT7789, FT8201, T10792, FT1296, FT7452, FT5665, T10793, FT1145, FT5670, FT1241, T10701, T10969, FT1759, FT5439, FT0058, FT4270, FT7793, FT2848, FT5441, FT2849, FT5447, FT2852, FT2853, FT1629, FT3347, FT1626, FT3348, FT1096, FT3895, FT1277, FT4037, FT4274, FT4583, FT7405, FT2823, FT7407, FT1323, FT7406, FT2762, T10855, FT1607, FT1006, T10858, T12135, FT0906, FT0406, FT7822, FT2234, FT1489, FT3594, FT8691, FT1528, FT1537, FT1552, T12179, T10865, FT1591, T12183, FT1091, T10873, FT1593, FT1696, FT8497, T10860, FT1089, FT1646, FT1592, T12533, FT7839, FT1632, FT1609, FT1170, FT0930, FT0788, FT1719, FT7837, FT1747, FT2583, FT1728, T10331, T10449, T12139, T12163, T12473, FT1754, FT1087, T12170, T10867, FT2683, T12028, FT7849, FT1917, FT7854, T12164, FT7827, T10321, FT6277, FT7866, T10337, T10333, FT1367, FT1780, FT7838, FT2501, FT7841, FB1310, T12168, T12042, FT1748, FT1850, FT1101, T12905, FT7860, FT1169, T10953, FT1864, FT3551, FT7900, T10753, T12238, FT1994, FT2042, FT7883, FT2019, FT7894, FT7907, FT7911, T12766, FT1171, T12041, FT7930, FT2176, FT7908, T10979, T12040, FT2206, FT2038, FT1337, T12060, FT0424, FT7906, T12044, FT2044, FT7909, T12059, FT8780, FT2342, FT2311, FT8814, FT8739, T12074, FT2393, FT8743, FT7913, FT3359, T12072, T13060, T13005, FT2430, FT1710, FT1583, T13017, T13065, FT2942, FT2534, FT9158, FT2535, FT9148, FT2496, FT2464, FT2537, FT5762, T12105, FT2490, FT2491, T13082, FT2426, FT2647, FT8268, FT2545, FT8253, T10973, T11030, FT7919, FT2722, T13191, FT1023 BFX#2, T12187, FT2544, T12201, FT2574, FT2580, FT2991, T12197, FT1020 BFX#4, T12198, FT2694, FT2715, FT2723, FT2718, FT2709, T11021, FT2802, FT1816, T12110, FT2803, T13125, FT7439A, FT7959, FT2805, FT7962, FT7965, T10992, T10999, T13255, FT1344, T11024, FT2755, FT2800, FT0171, T12339, FT1385, T12512, FT0716, FT2763, FT2819, T12378, FT2954, T12381, T12387, FT7979, FT7602, FT1717, FT6050, FT2956, FT2717, T12501, FT2829, FT1824, FT1471, FT1470, FT7929, FT2851, FT2892, FT7954, T12568, FT7956, FT2894, FT2923, FT7971, FT7981, FT1588, FT2367, FT2133, FT2870, FT1476, T12363, FT0933, FT4523, T12514, FT2921, FT7336, FT3057, T12565, T12567, FT7509, T12569, FT2992, FT7994, T12584, FT2004, T12090, T12585, FT2728, T12607, FT2757, FT4363, FT2203, FT3060, FT7992, FT7782, FT7997, FT7447, FT2972, FT7244, FT8049, FT5046, FT8502, FT3054, FT3605, FT2990, FT2519, FT3058, FT0935, FT9231, FT3247, FT4225, FT8335, FT8003, FT1098, FT1181, FT3324, FT3111, FT5564, FT3333, FT8288, FT3338, FT7991, FT8538, T12601, FT3246, FT3239, FT7543, T10174, T10176, FT2764, T10398, T12596, FT8882, T10395, T12606, FT3386, T10507, T12133, FT3334, FT8958, FT3350, T12488, FT3372, FT9068, FT8358, FT3373, FT9383, FT3371, T12486, FT3345, FT1484, FT7704, FT2940, T12839, T12633, FT3410, T12640, FT3409, T13185, T12671, FT9254, FT3388, T10160, T12655, FT3441, FT9250, FT1113, T13206, T10684, T12459, T12597, FT3428, FT2383, FT3440, FT8507, FT2387, FT8010, FT2482, FT0070, FT3462, FT1360, FT2329, FT9813, FT8008, FT2124, T12659, FT2327, T12617, FT3532, FT0321, T12618, FT1358, FT3533, FT8004, T12652, FT3482, FT8014, FT1362, FT3534, FT3483, FT2385, FT3539, FT3541, FT3543, FT5757, FT4657, FT3546, T12628, FT2123, T12629, FT5218, FT5225, FT8039, FT8040, T10517, FT3589, FT8001, FT8012, FT3586, FT8019, T12644, FT8017, FT4957, FT8027, FT8029, FT3300, FT8047, T10784, FT3194, FT1779, FT1483, FT3306, FT3540, FT1485, FT8052, T12740, FT3621, T12718, FT3645, FT1242, FT3893, FT8058, FT3899, FT8050, FT1254, FT4105, FT1104, FT8053, FT8056, FT8057, FT1460, FT1791, FT3885, FT3876, FT1255, FT3934, FT0859, T12974, T13027, FT3930, T13095, T13099, FT8064, FT1331, FT3984, FT7242, FT3996, FT3299, FT7248, FT3997, FT7296, FT3197, FT7362, FT7435, FT0099, FT1838, FT3977, FT7432, FT0308, FT1322 MIB Rev 11, FT7440, FT4035, FT7371, FT4102, FT4196, FT0036, FT8136, FT0440, FT7445, FT4131, FT0439, FT4759, FT4130, FT1321, FT0075, FT8051, FT0392, FT8066, FT4263, FT3186, FT0685, FT0872, FT1739, FT4763, FT0772, FT4284, FT0897, FT6061, FT4291, FT6134, FT4148, FT1010, FT0898, FT1099, FT3008, FT1017, FT4155, FT1139, FT1140, FT1076, FT1212, FT1431, FT6147, FT1777, FT1430, FT8121, FT1429, FT0714, FT1477, FT1570, FT7623, FT8113, FT1590, FT1809, FT4220, FT1589, FT4343, FT2400, FT2355, FT2590, FT8119, FT2948, FT1925, FT4428, FT8120, FT4346, FT2059, FT2893, FT2120, FT2871, FT2697, FT8144, FT7635, FT4147, FT8148, FT2112, FT7689, FT7690, FT4179, FT4206, FT2381, FT4360, FT7703, FT2565, FT4413, FT4446, FT7832, FT3464, FT3308, FT3443, FT7924, FT3467, FT4194, FT0034, FT4510, FT8246, FT0322, FT7801, FT3613, FT0561, FT1810, FT4525, FT0743, FT3999, FT4498, FT0773, FT4541, FT0858, FT8073, FT4453, FT0938, FT0838, FT4251, FT1078, FT1118, FT7008, FT4545, FT4254, FT1106, FT4521, FT5613, FT7043, FT3810, FT1279, FT7089, FT5468, FT1280, FT4543, FT1329, FT7110, FT4504, FT5470, FT1481, FT4567, FT5633, FT1794, FT7146, FT5113, FT1795, FT4655, FT1812, FT7162, FT8225, FT5638, FT8363, FT1922, FT3009, FT1814, FT2739, FT4626, FT2860, FT1815, FT7239, FT4618, FT2924, FT5639, FT4621, FT5640, FT4632, FT2858, FT7572, FT4628, FT3032, FT1954, FT4640, FT2854, FT1951, FT5646, FT4606, FT2009, FT7579, FT8337, FT5477, FT2113, FT4633, FT8359, FT2010, FT4607, FT2122, FT7581, FT5253, FT2255, FT4663, FT4561, FT8366, FT2224, FT3445, FT2319, FT2316, FT2384, FT2204, FT7764, FT2483, FT5459, FT3729, FT2484, FT4680, FT5475, FT2527, FT3769, FT4490, FT3622, FT4139, FT7823, FT3641, FT3639, FT7828, FT4697, FT5560, FT4076, FT4806, FT4736, FT7833, FT4505, FT7773, FT8385, FT4095, FT4786, FT5466, FT4802, FT4813, FT1861, FT8071, FT2657, FT7836, FT4776, FT4785, FT5084, FT3527, FT3733, FT4779, FT8105, FT4897, FT4905, FT4781, FT3592, FT4855, FT9426, FT3593, FT3513, FT4078, FT3720, FT9032, FT3597, FT3600, FT4073, FT9087, FT3815, FT9268, FT4074, FT4079, FT3816, FT8183, FT3736, FT3820, FT8191, FT3744, FT3821, FT3624, FT3739, FT8108, FT9471, FT4083, FT3831, FT9468, FT3740, FT2767, FT9479, FT2916, FT6016, FT3542, FT9486, FT8188, FT4864, FT9870, FT4885, FT8394, FT4907, FT4908, FT4909, T12399, FT4921, T12397, FT3651, FT4923, FT5498, FT4925, FT9489, FT8297, FT4935, FT9492, FT4939, FT4952, FT4961, FT4967, FT4996, T12188, FT5030, FT5502, FT8312, FT9550, T12383, FT2071, FT4200, FT8055, FT8382, FT8432, FT8559, FT4338, FT8384, FT5109, FT4330, T12143, FT5029, FT2795, FT8514, FT8395, FT5069, FT8400, FT8402, FT8424, FT5076, FT8429, FT5079, FT5068, FT8709, T10373, T10381, FT8722, FT8688, FT8721, FT8389, FT5170, FT8391, FT8682, FT5204, FT7334, FT8692, FT5200, FT7339, T12765, FT3864, T10254, FT8694, T13014, T13015, T13069, FT5224, FT3878, FT8695, FT5173, FT8697, T13132, FT2564, FT3135, FT5222, FT5181, FT7471, FT8746, FT8494, FT4177, FT8747, FT5158, FT8476, FT5167, FT8473, FT5228, FT5700, FT5175, FT5215, FT8763, FT7419, FT8773, T10340, FT5587, FT8755, FT8479, FT8808, FT5322, FT8478, FT8485, FT8819, FT8487, FT5595, FT7603, FT5318, FT6254, FT5584, FT5586, FT6246, FT8751, FT5591, FT5361, FT5589, FT6249, FT5597, FT5364, FT6251, FT5316, FT8804, FT8813, FT5372, FT7069, FT7088, FT8821, FT5572, FT8519, FT8077, FT5339, FT5189, FT8522, FT8528, FT8948, FT8530, FT8825, FT8534, FT8537, FT5676, FT5341, FT5472, FT8953, FT7574, FT7776, FT5698, FT8712, FT8085, FT8087, FT4565, FT8166, FT8338, FT8291, FT8025, FT8552, FT0886, FT5385, FT8941, FT8233, FT8554, FT1744, FT8943, FT5479, FT8232, FT8208, FT5320, FT8209, FT1038 BFX#6, FT8217, FT8293, FT8328, FT8295, FT9036, FT5430, FT8221, FT9309, FT5376, FT8223, FT8318, FT8320, FT9004, FT5480, FT8433, FT8438, FT8321, FT8421, FT8330, FT8423, T12023, FT8417, FT8326, FT8418, FT0889, FT8442, FT0970, FT5467, FT8436, FT9156, FT5478, FT8444, FT8331, FT9157, FT8448, FT8345, FT8419, FT9163, FT5327, FT0896, FT8759, FT5321, FT8587, FT9172, FT8555, FT0974, FT5319, FT0976, FT8450, FT8913, FT9166, FT5530, FT8607, FT9244, FT1036, FT5594, FT5526, FT9243, FT5583, FT8980, FT8979, FT5378, FT5377, FT9113, FT9247, FT5505, FT8598, FT0900, FT9131, FT5580, FT9344, FT9248, FT5582, FT9449, FT9249, FT5592, FT8594, FT9450, FT5611, FT8616, FT9251, FT8619, FT9253, FT9025, FT5454, FT9028, FT9027, FT9704, FT9026, FT9705, FT9029, FT1040, FT9115, FT5683, FT9090, FT1052, FT9733, FT9749, FT8706, FT5108, FT9751, FT9084, FT1278, FT1148, FT9204, FT1373, FT9323, FT5702, FT9759, FT9885, FT5723, FT9214, FT9893, FT5695, FT1906, FT5706, FT9490, FT9727, FT9319, FT9728, FT9729, FT9730, FT7201A, FT8665, FT8680, FT9539, T10112, FT9538, FT8664, FT5769, FT1372, FT5758, FT5727, T10118, FT8667, T10088, FT5795, T10203, FT9541, FT1638, T10650, T12313, FT9544, T12314, FT7227, FT5849, FT1377, T12312, FT7294, FT1519, FT9534, FT0628, FT8659, FT5880, FT8677, FT8689, FT7121, FT8690, FT7437, FT1295, FT7427, FT7469, T12319, FT5821, FT1379, T12588, FT1434, FT9535, FT9533, FT7549, T12589, FT1516, FT8683, T12590, FT1661, FT6086, FT5836, FT1752, FT1854, FT5840, FT8699, FT1928, FT8705, FT1386, T12032, FT5847, FT2211, FT2212, T12039, FT5894, T12146, FT7693, T12178, FT0255, FT5900, T12276, FT5813, T12281, FT5824, T12282, FT1527, T12285, FT8700, T12286, FT9604, FT9605, FT2642, T12289, FT2644, FT3326, FT3360, FT0917, FT2281, FT2285, FT2571, FT1090, T10001, FT2568, FT3927, FT3923, FT2166, FT3941, FT2168, FT5919, FT3924, FT2167, FT3925, FT5930, FT4441, T10097, FT5927, FT3955, FT0176, FT0192, FT0195, FT5600, FT3991, T10089, FT3786, FT8752, FT0132, T12621, FT9631, FT8754, FT4242, FT5983, FT4342, FT1745, T12681, T10108, FT5984, FT4359, FT8720, T12721, T10109, FT4435, FT8757, FT4436, FT8758, T12768, T10096, FT4433, T12829, FT4455, FT1070, T12956, FT1388, FT2284, FT4844, FT1387, FT4828, FT1389, FT4770, FT2282, T13176, FT4878, T13152, T10005, FT5250, FT1034, FT6026, FT4936, T13173, FT4934, FT6023, FT6020, FT6022, T13177, FT6021, FT2873, FT1247, FT6005, T13178, FT5994, FT4637, FT4713, FT4727, FT5697, FT0801, FT5991, FT5992, FT7557, FT0916, FT4747, FT7701, FT6095, FT6171, FT4405, FT7716, FT6056, FT6039, FT2175, FT2180, FT2646, FT6204, FT7561, FT0752, FT0750, FT6258, FT0749, FT0140, FT2003, FT8793, FT0148, FT0884, FT1050, FT5335, FT4126, FT4116, FT5445, FT4108, FT5675, FT0188, FT0181, FT5344, FT5345, FT6079, FT5351, FT6096, FT0305, FT1871… Full codes in the FDA record	10,129 units (2,836 US, 7,293 OUS)
Z-0594-2025	BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296; Catalog No: 442296; UDI-DI: 00382904422967; Serial Numbers: FF7385, FF7425, FF2727, FF1261, FF2717, FF1262, FF7254, FF7365, FF7419, FF7374, FF6762, FF2759, FF2756, FF7380, FF9548, FF9544, FF7367, FF2745, FF7615, FF2789, FF1371, FF7208, FF7481, FF7294, FF7225, FF7258, FF2760, FF9091, FF7875, FF6519, FF6835, FF2838, FF9860, FF7293, FF9668, FF9469, FF4440, FF9484, FF4506, FF9796, FF9602, FF2835, FF7238, FF2836, FF6984, FF9637, FF9689, FF9690, FF9700, FF9706, FF9743, FFA832, FFA846, FF9264, FF9734, FF6896, FF9735, FF9737, FF9800, FF2844, FF9633, FF0169, FF2954, FF1445, FF9838, FF3217, FF9642, FF9842, FF9339, FF1308, FF1314, FF1595, FF1341, FF1592, FF1375, FF9676, FF2875, FF2881, FF1448, FF9613, FF9614, FF1631, FF9271, FF9290, FF9753, FF9198, FF2324, FF9288, FF2914, FF5094, FF 2887, FF2978, FF9284, FF3960, FF2611, FF2979, FF4517, FF9278, FF4505, FF9279, FF9285, FF1414, FF9292, FF9297, FF9646, FF1417, FF5188, FF1460, FF2899, FF2921, FF1387, FF5098, FF9255, FF2922, FF9386, FF1391, FF1388, FFA256, FF9528, FF5178, FF9342, FF0756, FF6635, FF9447, FF6632, FF9639, FF6871, FF9641, FF2335, FF4464, FF9644, FF9458, FF9460, FFA366, FF5353, FF9479, FF9514, FF9522, FF7693, FF9594, FF7536, FF7687, FF7755, FF0877, FF0249, FF7510, FF7754, FF1837, FF7531, FF3484, FF3480, FF0988, FF3002, FF1501, FF0215, FF3385, FF3413, FF3384, FF1531, FF9015, FF3377, FF7547, FF7550, FF9022, FF9244, FF4570, FF7534, FF3218, FF3435, FF6636, FF7542, FF6885, FF3440, FF7182, FF9682, FF4627, FF7544, FF9684, FF7593, FF6663, FFA134, FF7538, FFA114, FF7555, FF7570, FF9000, FF7621, FF3549, FF7619, FF7622, FF9995, FF7694, FF7838, FFA052, FFA057, FF7887, FFA074, FF7688, FF7721, FF7719, FF7708, FF7711, FFA276, FF7845, FF4291, FF7842, FF7843, FF3553, FF7799, FF6390, FF6252, FF7095, FF3693, FF7765, FF3696, FF7771, FF3760, FF7775, FF3494, FF3516, FF9180, FF3589, FF9197, FFA616, FF3762, FF3899, FF9171, FF9182, FF3891, FF9188, FFA619, FF9190, FF4004, FF9124, FF4257, FF7770, FF4258, FF7773, FF4427, FF9193, FF4323, FFA744, FF2087, FFA973, FF2971, FF5701, FF7804, FF2171, FF2253, FF2874, FF2610, FF2100, FF2377, FF2431, FF9200, FF2151, FF9270, FF3868, FF3302, FF9273, FF2853, FF9275, FF2937, FF5770, FF2876, FF5092, FF9728, FF0248, FF9741, FF0607, FF1054, FF1107, FF3009, FF1404, FF1381, FF1585, FF0695, FF1998, FF3606, FF0171, FF0977, FF2024, FF1111, FF2025, ff6889, FF0598, FF1284, FF2379, FF9063, FF2219, FF6631, FF9053, FF2477, FF2972, FF2478, FF2141, FF7878, FF3318, FF3321, FF5300, FF0046, FF1997, FF2641, FF3609, FF3611, FF6728, FF0008, FF2697, FF0657, FF7444, FF2689, FF2685, FF0272, FF2776, FF9895, FF2782, FF9900, FF2783, FF6933, FF9729, FF0013, FF0265, FF9874, FF9404, FF3124, FF3120, FF2535, FF9877, FF9863, FF9866, FF9873, FF9876, FF3415, FF9882, FF9883, FF9894, FF9896, FF3740, FF2074, FF5192, FF0979, FF0652, FF1021, FF3819, FF3885, FF1871, FF0480, FF4164, FF9903, FF4370, FF4375, FF4460, FF4116, FF0057, FF4125, FF5656, 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FF3490, FF3717, FF0499, FF3585, FF1760, FF4425, FF3678, FF1158, FF4426, FF5675, FF4101, FF9420, FF4255, FF4775, FF6567, FF4776, FF6571, FF4814, FF5731, FF4735, FF7422, FF7421, FF6753, FF4937, FF9499, FF6947, FF7061, FF5154, FF4860, FF9554, FF2805, FF2884, FF3077, FF1960, FF5246, FF5475, FF5747, FF5693, FF6293, FF1977, FF2038, FF2090, FF2093, FF3052, FF6518, FF1561, FF9209, FF5717, FF9425, FF6134, FF9730, FF7796, FF2357, FFA063, FF2192, FF6189, FF7760, FF7697, FF1888, FF6309, FF2592, FF6340, FF6359, FF0999, FF0506, FF1876, FF3792, FF7504, FF7505, FF5805, FF5796, FF5802, FF3420, FF7295, FF5797, FF3417, FF3816, FF3807, FF5771, FF2832, FF6313, FF6339, FF6345, FF3028, FF3906, FF0205, FF9014, FF0206, FF6370, FF0285, FF6792, FF9239, FF6834, FF6839, FF5806, FF6726, FF0368, FF0377, FF5426, FF0710, FF6729, FF5403, FF0380, FF5406, FF0381, FF0711, FF5411, FF6758, FF6675, FF0475, FF6864, FF1330, FF6767, FF6751, FF6771, FF0219, FF6989, FF0785, FF6733, FF0899, FF1009, FF1166, FF9253, FF1325, FF1003, FF0297, FF7137, FF7145, FF7153, FF7085, FF7041, FF0300, FF7298, FF7198, FF1449, FF1451, FF1661, FF1006, FF7039, FF1289, FF1008, FF7032, FF9388, FF6611, FF5795, FF5785, FF6378, FF7354, FF1739, FF1717, FF7356, FF1429, FF0715, FF7359, FF9440, FF7361, FF9438, FF1013, FF9435, FF0222, FF5827, FF7144, FF1654, FF7491, FF5807, FF7496, FF5809, FF0110, FF7499, FF1259, FF0230, FF9492, FF1264, FF9493, FF9501, FF3172, FF3173, FF1266, FF5916, FF1764, FF1766, FF3066, FF9502, FF3143, FF0617, FF2263, FF0089, FF9636, FF1267, FF0088, FF2503, FF9530, FF2505, FF2676, FF2677, FF5863, FF2764, FF2766, FF5875, FF2769, FF7784, FF9780, FF7829, FF9783, FF9784, FF3145, FF5860, FF5876, FF0502, FF3282, FF7832, FF9758, FF3283, FF1061, FF7839, FF3288, FF5879, FF5880, FF7844, FF5388, FF1064, FF5892, FF5893, FF9092, FF0512, FF9093, FF9094, FF0520, FF9095, FF9111, FF5043, FF0302, FF5045, FF0525, FF9099, FF5046, FF9105, FF9109, FF9114, FF5220, FF5048, FF5218, FF1515, FF5219, FF0303, FF1516, FF0530, FF0305, FF0531, FF9786, FF9491, FF1521, FFA042, FF0533, FFA117, FF6793, FF0758, FF4321, FF5678, FF6799, FF5680, FF0759, FF7274, FF5682, FF7276, FF6027, FF0761, FF7279, FF6329, FFA105, FF7509, FF7549, FF7575, FF7581, FF6063, FF0763, FF7605, FF0241, FF7616, FF7714, FF0773, FF7716, FF7718, FF6121, FF3684, FF7724, FF1587, FF1121, FF1122, FF9534, FF1123, FF9535, FF9332, FF9552, FF9553, FF9513, FF9678, FF3004, FF2329, FF9686, FF9957, FF9958, FF6184, FF9963, FF6171, FF6012, FF6179, FF6276, FF6574, FF6536, FFA139, FF6238, FF0948, FF6270, FF0953, FF0635, FFA055, FF1614, FF5966, FFA171, FF1348, FF1422, FF1403, FF1570, FF1624, FF6303, FF1857, FF2086, FF2208, FFA195, FF7577, FF9880, FF0186, FF9899, FF9954, FF0197, FF9685, FF9618, FF6332, FF9980, FF9905, FF1368, FF1416, FF0331, FF2371, FF0334, FF0434, FF7647, FF0333, FFA257, FF9907, FF6331, FF5106, FF9952, FF5115, FF0776, FF9955, FF0778, FF6347, FF0340, FF9964, FFA297, FFA298, FF6377, FF6381, FF1421, FF0342, FF1494, FF0343, FF0401, FF1897, FFA096, FF7429, FF0707, FF0264, FFA622, FF0269… Full codes in the FDA record	8,085 units (838 US, 7,247 OUS)
Z-0595-2025	BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570; Catalog No: 445570; UDI-DI: 00382904455705; Serial Numbers: UB4523, UB3416, UB3975, UB3871A, UB3753, UB4823, UB3905, DB2572, UB4642, UB3414, UM1431, UB3731, UB1470, UB5555, UM1395, UB4212, UB3555, UB4159, UB4778, UB3805, UB1648, UB4562, UB4174, UB4325, UB1801, UB5086, UB1990, UB4002A, UB3103, UB3795, UB4274, UB4360, UB1611, UB4535, UB4542, UB4596, UB3338, UB4688, UB3480, UB4928, UB4929, UB1439, UB1583, UB5178, UB3122, UB3335, UB3229, UB4005, UB1682, UB3541, UB3599, UB3193, UB4184, UB1778, UB4405, UB3413, UB4271, UB4715, UB3210, UB4110, UB4112, UB3499, UB5405, UB5389, UB5442, UB5362, UB4995, UB1812, UB4427, UB4253, UB1708, UB3273, UM1273, UB4959, US1103, UB3383, UM1283, UM1269, UB5663, UB4384, UB5569, UB5470, UB5594, UB4185, UB5679, UB5527, UB5361, UB5579, UB4280, UB5535, UB4221, UB5596, UB5576, UB5588, UB5496, UB5610, UB3242, UB5537, UB5553, UB5565, UB5451, UB5505, UB5492, UB5507, UB5526, UB5691, UB5693, UB5694, UB5456, UB5609, UB5534, UB5631, UB5469, UB5541, UB3647, UB4048, UB4177, UB5415, UB5080, UB5529, UB5587, UB3398, UB5584, UB5414, UB5444, UB5474, UB5495, UB5523, UB5503, UB5431, UB3814, UB5550, UB5559, UB4661, UB5073, UB4776, UB5074, UB5059, UB5380, UB3491, UB4922, UB1862, UB4881, UB5093, UB2082, UB5079, UB4711, UB5101, UB5092, UB5108, UB5038, UB4704, UB4953, UB5026, UB5017, UB4188, UB5110, UB5041, UB5078, UB5118, UB5598, UB5111, UB5153, UB3634, UB5149, UB5005, UB5152, UB5164, UB5129, UB5050, UB5151, UB5165, UB5158, UB9654, UB5135, UB5207, UB5195, UB5171, UB5205, UB5117, UB5229, UB5241, UB5234, UB5230, UB5140, UB5167, UB5222, UB5255, UB5063, UB5199, UB5224, UB5265, UB5136, UB5283, UB5285, UB5304, UB5060, UB5289, UB5246, UB4369, UB5309, UB5302, UB5299, UB3148, UB5235, UM1331, UB1653, UB5420, UB3654, UB5329, UB4315, UB3026, UB3336, UB1501, UB3767, UB4334, UB5373, UB5791, UB5156, UB4560, UB5300, UB4519, UB5463, UB4340, UB4244, UB5472, UB3703, UB5296, UB5457, UB5317, UB3704, UB5465, UB5393, UB4356, UB3700, UB5279, UB5130, UB5297, UB4600, UB5471, UB5479, UB4545, UB4466, UB5428, UB5488, UB3851, UB5308, UB5253, UB3483, UB5298, UB4602, UB4471, UB5339, UB3812, UB4518, UB5324, UB5381, UB4504, UB5364, UB3785, UB5397, UB4539, UB4540, UB4420, UB5358, UB5433, UB3919, UB5434, UB4481, UB5425, UB5502, UB4346, UB4507, UB5371, UB5141, UB5379, UB3320, UB4610, UB5244, UB4554, UB4567, UB4620, UB4057, UB4424, UB4634, UB5218, UB4614, UB3894, UB5316, UB5483, UB5303, UB3863, UB5374, UB4115, UB5375, UB4583, UB4114, UB4392, UB5481, UB5353, UB4581, UB4006, UB4088, UB4751, UB5365, UB4666, UB1049, UB1523, UB3082, UB5466, UB5360, UB1734, UB5454, UB3062, UB2013, UB1689, UB3264, UB4571, UB5412, UB4684, UM1406, UB5581, UB1555, UB5319, UB4485, UB5589, UB4653, UB5406, UB4705, UB5396, UB1746, UB4706, UB5290, UB5432, UB4572, UB4117, UB4745, UB5543, UB4175, UB5514, UB5604, UB4730, UB3907, UB5372, UB4719, UB4681, UB4162, UB5245, UB4768, UB5388, UB4483, UB4718, UB5119, UB4139, UB5301, UB4232, UB5367, UB4723, UB5125, UB5382, UB5142, UB4747, UB3489, UB4641, UB4618, UB5061, UB4633, UB4817, UB4638, UB5418, UB4226, UB5417, UB4835, UB4643, UB4809, UB5262, UB5221, UB5422, UB5551, UB5261, UB4834, UB4756, UB4838, UB4812, UB4766, UB4810, UB4826, UB5621, UB4781, UB4861, UB4856, UB4859, UB4876, UB4854, UB5620, UB5540, UB4860, UB5538, UB4765, UB5560, UB5506, UB4755, UB5530, UB5585, UB5574, UB4902, UB4888, UB4886, UB3237, UB4870, UB4914, UB4880, UB4901, UB4906, UB4935, UB4932, UB4805, UB4917, UB4934, UB4918, UB4955, UB4905, UB4956, UB4944, UB4963, UB4916, UB4964, UB4969, UB4806, UB4979, UB4983, UB4135, UB5030, UB5013, UB4994, UB5004, UB5034, UB5020, UB4374, UB4478, UB4612, UB4651, UB4738, UB3718, UB3811, UB4463, UB3865, UB3868, UB3877, UB3878, UB3911, UB3123, UB3914, UB3915, UB5636, UB5638, UB5640, UB5642, UB5641, UB3940, UB5646, UB5650, UB5654, UB1248, UB9256, UB5347, UB5345, UM1239, UB1792, UB0031, UB3709, UB4154B, UB4740, UB4732, UB3479, UB1793, UB1750, UB1057, UB1609, UB3139, UB3853, UB3205, UB3448, UB3539, UB3779, UM1180, UM1201, UB0097, UM1345, UM2069, UB1048, UB3696, UB5102, UB5209, UB5607, UB3655, UB5561, UB5517, UB4461, UB5180, UB3948, UB3852, UB3984, UB3265, UB5036, UB4930, UB1671, UM1403, UB3952, UB5668, UB5015, UB4899, UB4129, UB4093, UB4894, UB3191, UB3595, UB4981, UB4147, UB5133, US1048, UB4260, UB4587, UB3275, UB4565, UB5268, UB5392, UB5453, UB4986, UB4475, UB5387, UB5196, UB5042, UB5443, UB5210, UB3813, UB3658, UB5223, UB4637, UB3561, UB5459, UB4201, UB4703, UB3013, UB4052, UB1977, UB5132, UB5064, UB5175, UB5247, UB4419, UB4862, UB4866, UB5557, NB3896, UB5292, UB4412, UB3553, UB4700, UB1672, UB4489, UB4491, UB5404, UB5002, UB4113, UB4487, UB3876, UB4259, UB1657, UB3170, UB1892, UB1925, UB4658, UB1716, UB5105, UB3010, UB4379, UB3409, UB5021, UB3259, UB1891, UB1668, UB1878, UB5344, UB5342, UB5512, UB5441, UB5137, UB5052, UB3721, UB2051, UB5286, UB3396, UB4181, UB2041, UB3950, UB5024, UB4394, UB5661, UB5662, UB5511, UB5563, UB5675, UB1553, UB5623, UB5508, UB5676, UB5608, UB5685, UB5447, UB5546, UB5341, UB5409, UB5438, UB5318, UB5577, UB5413, UB5625, UB5522, UB5545, UB5570, UB5627, UB5595, UB5485, UB5352, UB5462, UB5572, UB5612, UB3745, UB5593, UB5548, UB5619, UB5700, UB5586, UB5567, UB5582, UB5583, UB5439, UB5613, UB5578, UB5532, UB5562, UB5599, UB5571, UB5615, UB5558, UB5519, UB5590, UB4043, UB4220, UB5084, UB5057, UB5043, UB5053, UB5076, UB5087, UB5071, UB5099, UB5068, UB5077, UB5098, UB5066, UB5029, UB5070, UB5094, UB5045, UB5095, UB5122, UB5085, UB5022, UB4977, UB5104, UB5116, UB5124, UB5072, UB5120, UB5138, UB5145, UB5147, UB5155, UB5157, UB5169, UB5170, UB8041, UB5168, UB5146, UB5143, UB5096, UB4731, UB4904, UB5160, UB5106, UB5201, UB5197, UB5618, UB5154, UB5225, UB5243, UB5206, UB5212, UB4873, UB4631, UB5254, UB5267, UB5184, UB5211, UB5203, UB5194, UB5240, UB5219, UB5677, UB5277, UB5148, UB5242, UB5294, UB5239, UB5275, UB5131, UB5305, UB5295, UB5326, UB5573, UB5282, UB5368, UB3055, UB5385, UB3570, UB5270, UB5314, UB3042, UB5323, UB3493, UB5461, UB5429, UB4231, UB3636, UB3706, UB1934, UB3424, UB4245, UB5313, UB5359, UB5284, UB5416, UB5458, UB5260, UB5467, UB4333, UB4354, UB5435, UB4339, UB4872, UB5306, UB4342, UB5272, UB3768, UB5159, UB4355, UB5338, UB5202, UB4423, UB5516, UB5486, UB5327, UB5370, UB3800, UB4438, UB5320, UB5348, UB4205, UB3750, UB4505, UB5322, UB5307, UB5357, UB3771, UB5256, UB4410, UB4510, UB5331, UB5424, UB5489, UB4566, UB5123, UB4011, UB5408, UB4553, UB3350, UB4068, UB4486, UB4558, UB4070, UB5264, UB4083, UB5334, UB4503, UB4482, UB4498, UB5377, UB4555, UB5494, UB5177, UB5355, UB4648, UB4116, UB5500, UB4474, UB4680, UB5293, UB4720, UB5335, UB5291, UB5468, UB4773, UB5473, UB4102, UB5198, UB5455, UB5399, UB5259, UB4178, UB4685, UB4721, UB5386, UB5366, UB4105, UB4758, UB4775, UB4764, UB5491, UB5515, UB5448, UB4743, UB4759, UB5501, UB5394, UB5449, UB4464, UB5419, UB5346, UB4686, UB4163, UB5263, UB4225, UB5407, UB4763, UB5310, UB5340, UB5450, UB4767, UB5332, UB4237, UB5383, UB5333, UB4761, UB4782, UB4422, UB4871, UB5232, UB5351, UB4821, UB4671, UB5069, UB5597, UB4807, UB5547, UB4837, UB4804, UB5611, UB5464, UB5624, UB5436, UB5552, UB5549, UB4855, UB4878, UB4748, UB5518, UB5564, UB5440, UB4762, UB5498, UB4892, UB4462, UB5437, UB4885, UB4780, UB5112, UB4848, UB5065, UB5173, UB4779, UB4879, UB5533, UB4889, UB5524, UB4887, UB4852, UB4909, UB4882, UB4717, UB4948, UB4936, UB4939, UB4942, UB4853, UB4839, UB4744, UB4836, UB4891, UB4777, UB4954, UB2083, UB4884, UB4808, UB3132, UB4774, UB4965, UB4957, UB4403, UB4933, UB3680, UB4968, UB4984, UB4989, UB4679, UB4940, UB4769, UB2027, UB4198, UB4970, UB5037, UB5031, UB4982, UB5018, UB5014, UB4985, UB5044, UB4927, UB3432, UB4608, UB4632, UB4644, UB1983, UB4084, UB5602, UB5614, UB5622, UB5616, UB5634, UB3912, UB5630, UB3929, UB5645, UB5643, UB5649, UB5651, UB5653, UB5655, UB4064, UB2126, UB3304, UB3366, UB3481, UB4913, UM1179, UM1730, US1113, UB3440, UB4047, UB4261, UB4456, UB4425, UB4497, UB4820, UB4911, UB3452, UB1458, UB3482, UB6515, UB4173, UB4534, UB4662, UB1952, UM5032, UB4381, US1125, UB4363, UB4515, UB4692, UB4695, UB4365, UB4273, UB4603, UB4657, UB1629, UB4347, UB4697, UB4582, UB1673, UB4303, UB4351, UM1350, UB1697, UB4530, UB4490, UB3946A, UB4577, UB4598, UB4561, UB4604, UB4592, UB3677, UB3065, UB4296, UB4587A, UB4750, UB3318, UB4771, UB3770, UB3007, UB3992, UB3971, UB1474, UB3964, UB4050, UB3976, UB4868, UB4059, UB4101, UB1622, UB4617, UB1519, UB3004, UB1813, UB4298, UB1912, UB4179, UB4285, UB3286, UB3299, UB4118, UB4209, UB4432, UB1915, UB4670, UB4263, UB3310, UB4621, UB4301, UB4211, UB4270, UB2076, UB3023, UB3197, UB3411, UB3157, UB2026, UB2022, UB4319, UB3324, UB1893, UB3333, UB4429, UB1713, UB4233, UB3445, UB3296, UB3272, UB3225, UB2078, UB3377, UB3236, UB3332, UB4446, UB3648, UB4707, UB3551, UB3513, UB4712, UB4401, UB3303, UB3317, UB4343, UB4945, UB5249, UB5010,	1,087 units (136 US, 951 OUS)
Z-0596-2025	BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475; Catalog No: 445475; UDI-DI: 00382904454753; Serial Numbers: DB5631, DB 6970, DB6857, DB6859, DB6122, DB3043, MD1710, DB4372, DB6043, DB2249, DB5030, DB2882, DB3090, MD2046, DB4927, DB5825, DB2828, DB2835, DB3251, DB3245, DB6893, DB3145, DB3211, DB5876, DB5906, DB4284, DB5948, DB3143, DB3204, DB6891, PM4385R, DB5761, DB4811, DB4718, DB3231, DB2786, DB4793, DB2322, DB6522, DB4820, DB2216, DB6558, DB4113, DB5168, DB2544, DB6674, DB4263, DB4842, DB6369, DB6900, DB4828, DB4418, DB5204, DB5282, DB4286, DB5569, DB5626, FS1472, FS1473, FS1230, FS1234, DB2702, DB4367, DB6655, DB6920, DB4365, DB2219, FT1004, DB6156, DB6961, DB2421, DB5244, DB2530, DB2844, DB4890, DB5146, DB5443, DB6011, DB5940, DB6628, DB3318, DB2417, MD1748, DB6315, DB4134, FS1320, DB3307, DB4304, MD2027, DB4152, MD1851, FS1280, DB2152, DB6243, DB4680, FS1004, FS1094, FS1001, DB6570, DB6391, DB6393, DB3004, DB4706, DB4248, DB6392, DB4260, DB6573, DB6571, DB2840, DB6584, DB2974, DB6634, DB4267, DB4440, DB2548, DB4449, DB6491, DB6903, DB4892, DB5529, DB2925, DB6595, DB5538, DB4271, DB6936, DB4987, DB2337, DB3389, DB3340, DF1540, DB2332, DB7013, DB4492, FS1178, FS1519, DB4565, DB4589, DB4028, DB6430, DB3076, DB6258, MD1730, MD1810, DB4586, DB5340, DB6499, DB5347A, DB5398, DB6603, MD2086, DB6113, DB2884, DB4733, DB4739, DB2804, DB4631, DB2276, DB4506, DB3024, DB6123, DB6590, DB4557, DB6281, 94707, DB6426, DB6657, DB6933, DB6658, DB4936, DB6324, DB2561, DB5865, DB5163, DB5005, DB6745, DB5200, DB5878, DB6709, DB4869, DB6058, DB6646, DB6645, DB6843, DB5094, DB4917, DB6845, DB6863, DB7074, DB7003, DB7071, DB7004, DB6994, DB7041, DB7133, DB7132, DB7167, DB6755, DB7187, DB7144, DB7142, DB6451, DB6689, DB7199, DB7182, DB7203, DB7136, DB5880, DB6896, DB6464, DB6679, FS1426, MD1634, DB1679, DB7050, DB6342, DB6872, DB2657, DB6576, DB6719, DB6938, DB4377, DB7000, DB6733, FS1400, DB2556, MD1750, DB6237, DB5602, DB7007, DB7008, DB6883, DF1563, DB6950, DB6559, DB6951, DF1562, DB6918, DB5858, DB5350, DB6041, DB4998, DB6484, DB6505, DB5363, DB6792, DB7212, DB5381, DB5422, DB5682, DB5653, DB5429, DB5784, FS1494, DB2516, DB4662, DB4665, MD1793, MD1794, DB4763, DB6809, MD1916, DB5905, MD1610, MD1840, DB2160, DB7178, DB6302, DB6165, MD1925, MD2056, MD2122, DB5596, DB5919, DB5861, DB5862, DB5813, DB5937, DB5089, DB6034, DB2403, MD1619, DB7157, DB2453, DB2424, DB5215, DB1059, DB2238, DB4020, DB5740, DB5065, DB6858, DB5955, DB2244, DB5021, DB3086, DB4776, 97R4YC2, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB5491, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, DB3279, DB3349, DB4149, DB 5844, DB 5845, DB5847, DB 5997, DB 5846, DB5888, DB5683, DB4805, DB6802, DF1547, DB6218, DB6685, RC1164, DB2212, DB3212, DB4868, DB4891, DB4478, DB4742, DB5096, DB4855, DB6262, DB5668, DB2384, DB6024, DB6071, DB7101, DB7098, DB7100, DB6018, DB6036, DB2939, DB2967, DB5286, DB2146, FS1073, DB7120, DB5522, DB2977, DB6096, DB6483, DB6604, DB6640, DB6750, DB6670, DB6814, DB6815, DB7099, DB6990, DB7122, DB7110, DB6736, DB7139, DB7140, DB7190, DB7180, DB7191, DB7194, DB7216, DB7204, DB7205, DB7197, DB7173, DB2312, DB6597, DB5077, DB3291, DB4538, DB6155, DB6485, DB6486, DB6487, DB6488, DB7062, DB7185, DB4344, DB4453, DB4952, MD1771, MD1877, DB4138, DB6142, DB6477, MD1847, FS1470, FS1476, DB5084, FS1244, MD2047, DB5302, DB7030, DB2170, DB4816, DB5620, DB5169, DB5507, DB5737, DB5202, DB6811, DB7034, DB2220, DB5525, DB2221, DB6715, DB6708, DB6734, DB6781, DB2588, DB6780, DB7054, DB6268, DB2204, DB5696, DB6403, DB2737, DB5643, DB6717, DB2660, DB6591, DB6911, DB2633, DB5743, DB6852, DB2357, DB2758, DF1552, DB6790, TBD1234, DB6786, DB6323, DB6996, DB6941, DB6850, DB6907, DB6980, DB6952, DB5449, DB5375, DB5373, DB7076, DB4234, DB5608, DB5407, DB5652, DB5430, DB5512, DB4550, DB5594, DB7097, DB6213, DB5550, MD1832, DB2493, DB5083, MD1917, DB5734, DB7175, DB5911, DB5756, DB7176, DB7179, DB5800, DB5914, MD1611, DB2705, DB2377, MD1615, DB2378, DB6032, DB6054, DB6861, DB6494, DB4055, DB2845, DB6357, DB4083, DB4225, DB6121, DB4635, DB4078, DB6383, DB6671, DB6381, DB2819, DB3154, FS1011, DB2966, FS1193, DB6532, DB2818, DB6291, DB6283, MD1791, DB6617, DB6457, DB3124, DB4835, DB6169, DB4682, DB4596, DB6212, DB4649, DB4366, DB7096, DB6929, DB6978, DB6913, DB6319, FS1485, FS1341, DB2178, DB2619, FS1270, DB6240, MD1690, DB6317, DB6239, DB6300, DB4872, DB4441, DB2998, DB6581, DB6540, DB4451, DB6635, DB6699, DB2335, FS1461, DB6160, FS1204, DB5325, DB6161, FS1520, DB4206, DB4024, DB4765, FS1419, DF1596, MD1624, DB4619, DB6242, DB6496, DB4321, DB6331, DB6241, DB6667, DB4759, DB4322, DB4326, DB4752, DB4338, DB6339, DB3054, DB6989, DB4594, DB4938, DB4939, DB7022, DB7023, DB5177, DB5232, DB5205, DB5242, DB5274, DB7040, DB6905, DB2163, DB6065, DB6993, DB2620,	584 units (313 US, 271 OUS)

Based on the official FDA remedy

What to do — step by step

Update Security Credentials
Contact Becton Dickinson to update the product service credentials for your instrument to prevent unauthorized access.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 41 days after the firm started it.

Oct 31, 2024Firm started the recall
Dec 3, 2024FDA classified it Class II
Dec 11, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53603-bd-cor-gx-instrument-model-443990-unauthorized-access-risk">BD COR GX Instrument Model 443990: Unauthorized Access Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0589-2025 (October 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0589-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.