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Unrated Medical device recall · FDA · Published October 9, 2024

Medline Port Insertion Packs Recalled Due to Smoke Evacuation Pencil Hazard

Medline recalls convenience kits labeled PORT INSERTION PACK with specific model numbers due to potential safety risks from recalled SafeAir Smoke Evacuation Pencil.

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

🇺🇸 FDA recall #Z-0632-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling convenience kits labeled PORT INSERTION PACK with model numbers DYNJ81597. These kits were made using SafeAir Smoke Evacuation Pencil that was previously recalled by Stryker, raising safety concerns. Read more at govinfonow.com/recall/53736-medline-port-insertion-packs-recalled-due-to-smoke-evacuation-pencil.

Source Summary by GovInfoNow · govinfonow.com/recall/53736-medline-port-insertion-packs-recalled-due-to-smoke-evacuation-pencil · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0632-2025

Cite this page

“Medline Port Insertion Packs Recalled Due to Smoke Evacuation Pencil Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53736-medline-port-insertion-packs-recalled-due-to-smoke-evacuation-pencil. Based on FDA recall #Z-0632-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0632-2025%22&limit=1).

The FDA announced on October 9, 2024, that Medline Industries LP is recalling MEDLINE convenience kits labeled as PORT INSERTION PACK, REF DYNJ81597 due to the use of certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. This voluntary Class II recall affects 44 units distributed nationwide.

How to tell if you have it

  • Brand: Medline
  • Product: MEDLINE convenience kits labeled as PORT INSERTION PACK, REF DYNJ81597
  • UDI/DI: 10195327124007 (each), 40195327124008 (case)
  • Lot Numbers: 22IBF254, 23BBO299
  • Quantity: 44 units

The hazard

The recalled medical convenience kits were manufactured using certain lots of SafeAir Smoke Evacuation Pencils that had been previously recalled by Stryker. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since October 22, 2021. Other recent recalls of similar products include Medline medical kits regarding light failure in newborn resuscitation kits (July 25, 2025), Medline Foley Tray Kits with incorrect labeling risk (July 23, 2025), and Medline ReNewal Reprocessed St. Jude Catheters that may contain particulates (July 14, 2025). Additional recent recalls of similar products include Medline convenience kits recalled due to potentially contaminated components (July 10, 2026) and Medline Breast Pack Kits recalled due to regulatory clearance rescinded (February 25, 2026).

How to tell if you have this one

Check for Medline convenience kits labeled PORT INSERTION PACK with model numbers DYNJ81597. Look for lot numbers 22IBF254 or 23BBO299 on the packaging.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 28 products

All 28 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
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0622-2025MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J; 1) REF DYNJ85691, UDI/DI 10195327534141 (each) 40195327534142 (case), Lot Numbers: 24ABR853; 2) REF DYNJ902123J, UDI/DI 10195327497453 (each) 40195327497454 (case), Lot Numbers: 23JDB498, 24DDA877, 24CDB678, 24BDB73788 units
Z-0623-2025MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D; 1) REF DYNJ0572894I, UDI/DI 10195327045975 (each) 40195327045976 (case), Lot Numbers: 22EBV549, 22FBV442, 23ABU908, 22LBG711, 23CBJ089, 23BBM090, 23GBS959, 23JBG841; 2) REF DYNJ34418L, UDI/DI 10193489969276 (each) 40193489969277 (case), Lot Numbers: 23CBT026, 23ABO601; 3) REF DYNJ34418M, UDI/DI 10195327384371 (each) 40195327384372 (case), Lot Numbers: 23GBA504; 4) REF DYNJ900287D, UDI/DI 10193489798289 (each) 40193489798280 (case), Lot Numbers: 23BBT640, 23FBF622, 23GBL588, 23FBV779, 23EBF038,182 units
Z-0624-2025MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591; 1) REF DYNJ39185D, UDI/DI 10195327157166 (each) 40195327157167 (case), Lot Numbers: 22GBA088, 22FBS934, 22HBA086; 2) REF DYNJ44997J, UDI/DI 1019532738093 (each) 40195327380930 (case), Lot Numbers: 23GBU050, 23KBI422, 23JBL004, 23IBB532, 23LBK392, 24BBA287, 24CBM430; 3) REF DYNJ58409C, UDI/DI 10193489957242 (each) 40193489957243 (case), Lot Numbers: 22GBT985, 22LBD309, 23JBP407; 4) REF DYNJ66252A, UDI/DI 10193489887853 (each) 40193489887854 (case), Lot Numbers: 22OBL262; 5) REF DYNJ909591, UDI/DI 10195327413613 (each) 40195327413614 (case), Lot Numbers: DYNJ9095911271 units
Z-0625-2025MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK, REF CDS840459R; 8) CAROTID-LF, REF CDS860039K; 9) CAROTID-LF, REF CDS860039L; 10) OPEN HEART ADULT KIT, REF CDS981319AD; 11) BAPTIST AAA, REF CDS982400M; 12) ZALE PUMP CDS, REF CDS983187G; 13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G; 14) MAJOR VASCULAR, REF CDS983489K; 15) CAROTID, REF CDS983495N; 16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 17) AV FISTULA, REF CDS983638K; 18) PERIPHERAL VASCULAR CDS, REF CDS983723I; 19) ACH OPEN HEART, REF CDS983773J; 20) VASCULAR, REF CDS984255K; 21) VASCULAR CDS, REF CDS984275I; 22) OPEN HEART CDS, REF CDS984276O; 23) OPEN HEART CDS, REF CDS984355G; 24) OPEN HEART CDS, REF CDS984355I; 25) SMH VASCULAR CDS, REF CDS984584M; 26) VASCULAR CDS-LF, REF CDS984594G; 27) VASCULAR CDS-LF, REF CDS984594I; 28) VASCULAR, REF CDS985355F; 29) SJ BYPASS LEG CUSTOM PACK-LF, REF DYNJ0042944J; 30) SJ BYPS LEG CSTM PK RFID-LF, REF DYNJ0042944K; 31) AV FISTULA PACK-LF, REF DYNJ0131782G; 32) AV FISTULA PACK-LF, REF DYNJ0131782I; 33) AV FISTULA PACK-LF, REF DYNJ0131782J; 34) AV FISTULA PACK-LF, REF DYNJ0131782K; 35) VASCULAR PACK, REF DYNJ02467M; 36) OPEN HEART PACK A & B, REF DYNJ0283397U; 37) VASCULAR PACK-LF, REF DYNJ0421380P; 38) MAJOR VASCULAR PACK-LF, REF DYNJ0488546J; 39) SJ CARDIAC A PACK RFID-LF, REF DYNJ0619768M; 40) SJ PACEMAKER PACK RFID-LF, REF DYNJ0619848O; 41) PACEMAKER PACK-LF, REF DYNJ0826630N; 42) AV SHUNT PACK-LF, REF DYNJ0842516G; 43) GENERAL ENDO PACK-LF, REF DYNJ0842873K; 44) PACEMAKER PACK-LF, REF DYNJ0843217M; 45) PACEMAKER PACK-LF, REF DYNJ0843217N; 46) PACEMAKER PACK-LF, REF DYNJ0867353I; 47) PACEMAKER PACK-LF, REF DYNJ0867353J; 48) CAROTID ARTERY PACK-LF, REF DYNJ0882509L; 49) CAROTID ARTERY PACK-LF, REF DYNJ0882509N; 50) VASCULAR PACK-LF, REF DYNJ0901358J; 51) VASCULAR PACK-LF, REF DYNJ0901358K; 52) HEALTH ALL VASCULAR PACK-LF, REF DYNJ19538F; 53) OPEN HEART A&B PK-LF, REF DYNJ20888K; 54) OPEN HEART A&B PK-LF, REF DYNJ20888L; 55) GEN FEM POP #14-RF, REF DYNJ21877W; 56) CABG PACK A&B, REF DYNJ21971AD; 57) VASCULAR PACK, REF DYNJ22350L; 58) SVMMC CORE OPEN HEART PACK-LF, REF DYNJ22971T; 59) OPEN HEART SUPPLEMENT A, REF DYNJ24591AB; 60) SVMMC OPEN HEART ADD ON PACK, REF DYNJ24634O; 61) SVMMC PERMANENT PACING PACK, REF DYNJ24746I; 62) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 63) PACEMAKER PACK, REF DYNJ30928O; 64) VASCULAR PACK, REF DYNJ31902N; 65) DB CAROTID PACK-LF, REF DYNJ33579F; 66) DB ENDOVASCULAR AAA PACK-LF, REF DYNJ33689I; 67) PACEMAKER ICD PK, REF DYNJ34795K; 68) OPEN HEART PACK A&B, REF DYNJ35854D; 69) PACEMAKER PACK, REF DYNJ36025D; 70) RRMC PACEMAKER PACK, REF DYNJ36337G; 71) OPEN HEART PACK, REF DYNJ37284J; 72) PACEMAKER PACK, REF DYNJ37557D; 73) PEDIATRIC CARDIAC MINOR, REF DYNJ37618D; 74) ACH CABG ADD-ON, REF DYNJ38175L; 75) PACEMAKER SET UP PACK, REF DYNJ38232B; 76) PACEMAKER PACK-LF, REF DYNJ38643F; 77) PACEMAKER PACK-LF, REF DYNJ38702A; 78) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439K; 79) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439L; 80) CARDIOVASCULAR PACK, REF DYNJ42921G; 81) CABG PACK-LF, REF DYNJ43207K; 82) HEART DRAPING PACK-LF, REF DYNJ43214F; 83) VASCULAR PACK, REF DYNJ43276I; 84) SVMMC VASCULAR MAJOR PACK, REF DYNJ43777J; 85) OPEN HEART PACK A AND B, REF DYNJ43858B; 86) SVMMC CAROTID PACK, REF DYNJ43861F; 87) MAJOR VASCULAR PACK, REF DYNJ44161G; 88) MINOR VASCULAR PACK, REF DYNJ44164F; 89) VASCULAR ACCESS PACK, REF DYNJ44172D; 90) AV FISTULA PACK, REF DYNJ44704J; 91) AAA PACK, REF DYNJ44847I; 92) CARDIAC VASCULAR PACK, REF DYNJ44854M; 93) CASTRO CABG-COMPONENT PACK, REF DYNJ44857S; 94) CASTRO CABG-COMPONENT PACK, REF DYNJ44857T; 95) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 96) FIST; 1) REF CDS840232L, UDI/DI 10195327013691 (each) 40195327013692 (case), Lot Numbers: 22FBF374, 22FBX255, 23EBQ492, 23CBW366, 23CBW387, 23IBS976; 2) REF CDS840233I, UDI/DI 10195327065270 (each) 40195327065271 (case), Lot Numbers: 22GBJ144, 22FBO691, 22HBS387, 23BBG362, 23DBD583, 23GBU961, 23GBU784; 3) REF CDS840261AB, UDI/DI 10195327104535 (each) 40195327104536 (case), Lot Numbers: 22FBX514, 22IBE745, 23ABG192, 22KBO918, 23DBE827; 4) REF CDS840387T, UDI/DI 10195327070946 (each) 40195327070947 (case), Lot Numbers: 22FBS963, 22HBO062; 5) REF CDS840402AF, UDI/DI 10195327144029 (each) 40195327144020 (case), Lot Numbers: 22ELB107, 22ELA850, 22FLA766; 6) REF CDS840402AI, UDI/DI 10195327334024 (each) 40195327334025 (case), Lot Numbers: 23DLA845, 23GLA701, 23GLA627, 23HLA275, 23LLA792; 7) REF CDS840459R, UDI/DI 10195327194598 (each) 40195327194599 (case), Lot Numbers: 22HBR722, 23IBD831, 23IBD869, 23JBR310; 8) REF CDS860039K, UDI/DI 10195327009397 (each) 40195327009398 (case), Lot Numbers: 22FBF456, 23ABP502, 23DBE091, 23HBU269; 9) REF CDS860039L, UDI/DI 10195327533281 (each) 40195327533282 (case), Lot Numbers: 23KBT206; 10) REF CDS981319AD, UDI/DI 10195327547226 (each) 40195327547227 (case), Lot Numbers: 24AMI772; 11) REF CDS982400M, UDI/DI 10195327034566 (each) 40195327034567 (case), Lot Numbers: 23JBB859, 23KBT042, 24CBH306; 12) REF CDS983187G, UDI/DI 10195327258528 (each) 40195327258529 (case), Lot Numbers: 23EBK193, 23BBN996, 23BBN811, 23ABC476, 23EBG037; 13) REF CDS983481G, UDI/DI 10195327497347 (each) 40195327497348 (case), Lot Numbers: 23LDA076, 23KDC290, 24BDA534, 24DDA867; 14) REF CDS983489K, UDI/DI 10195327497279 (each) 40195327497270 (case)… Full codes in the FDA record30092 units
Z-0626-2025MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C; 1) REF DYNJ00281O, UDI/DI 10193489962963 (each) 40193489962964 (case), Lot Numbers: 22KMA417, 22FMD671; 2) REF DYNJ0101291F, UDI/DI 10195327286644 (each) 40195327286645 (case), Lot Numbers: 23FDA396, 23HDA759, 23EDB388, 23LDB909; 3) REF DYNJ0488546K, UDI/DI 10195327505097 (each) 40195327505098 (case), Lot Numbers: 23IBP983; 4) REF DYNJ84762, UDI/DI 10195327413088 (each) 40195327413089 (case), Lot Numbers: 23IMA327, 23IMA727; 5) REF DYNJ906907C, UDI/DI 10195327376819 (each) 40195327376810 (case), Lot Numbers: 23DBM940, 23FBG165, 23IBQ680—
Z-0627-2025MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691; 1) REF DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824; 2) REF DYNJ0842590G, UDI/DI 10195327286439 (each) 40195327286430 (case), Lot Numbers: 23HDA481, 23DDB914, 23DDA319; 3) REF DYNJ41473G, UDI/DI 10193489983982 (each) 40193489983983 (case), Lot Numbers: 22KMD254, 23KBD038, 23EMK120, 23CMA828; 4) REF DYNJ41473I, UDI/DI 10195327584931 (each) 40195327584932 (case), Lot Numbers: 24DBF911; 5) REF DYNJ44148G, UDI/DI 10195327412487 (each) 40195327412488 (case), Lot Numbers: 23EBV384, 23JBW504, 23KBG481; 6) REF DYNJ81776A, UDI/DI 10195327515881 (each) 40195327515882 (case), Lot Numbers: 23LBN724, 24CBH515; 7) REF DYNJ82691, UDI/DI 10195327202934 (each) 40195327202935 (case), Lot Numbers: 23GMI494, 23JMH927980 units
Z-0628-2025MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140; 1) REF DYNJ52404I, UDI/DI 10195327339159 (each) 40195327339150 (case), Lot Numbers: 23HDB384, 23IDC338; 2) REF DYNJ59073B, UDI/DI 10195327200398 (each) 40195327200399 (case), Lot Numbers: 23CBG401, 22JBI913, 23GBU324, 23EBL522, 23BBA464, 23CBU743, 23IBS781; 3) REF DYNJ80226A, UDI/DI 10195327195021 (each) 40195327195022 (case), Lot Numbers: 22GBV225, 22FBV173, 22FBV174; 4) REF DYNJ83140, UDI/DI 10195327232955 (each) 40195327232956 (case), Lot Numbers: 22JBN386944 units
Z-0629-2025MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072; 1) REF CDS983184I, UDI/DI 10195327178352 (each) 40195327178353 (case), Lot Numbers: 22LBB795, 23FBJ754, 23BBH106, 23CBT619, 23HBY087, 23HBP974, 23KBI669, 23LBD939, 23KBM394; 2) REF CDS983466L, UDI/DI 10195327497217 (each) 40195327497218 (case), Lot Numbers: 23JDB850, 23IDB539, 23KDB596, 24DDB278, 24DDA871, 24BDA878, 24ADA819, 24CDB315; 3) REF CDS983486K, UDI/DI 10195327497200 (each) 40195327497201 (case), Lot Numbers: 23JDA349, 24CDA873, 24ADA731, 24ADB821; 4) REF CDS984259N, UDI/DI 10193489862232 (each) 40193489862233 (case), Lot Numbers: 22KBJ788, 22JBH993, 22JBH284, 22LBB413; 5) REF CDS984259O, UDI/DI 10195327297817 (each) 40195327297818 (case), Lot Numbers: 23ABM783, 23ABK571; 6) REF CDS984282L, UDI/DI 10195327438920 (each) 40195327438921 (case), Lot Numbers: 23LMA461; 7) REF CDS984895I, UDI/DI 10193489983814 (each) 40193489983815 (case), Lot Numbers: 22FBL382, 22KBD792, 23DBM334, 23ABM451, 23FBK273; 8) REF CDS984895J, UDI/DI 10195327469092 (each) 40195327469093 (case), Lot Numbers: 23KBH104, 23KBH045; 9) REF CDS984895K, UDI/DI 10195327620875 (each) 40195327620876 (case), Lot Numbers: 24BBQ203, 24CBM385; 10) REF DYNJ0101206D, UDI/DI 10195327028855 (each) 40195327028856 (case), Lot Numbers: 22EMG943, 22GMB620; 11) REF DYNJ0101206F, UDI/DI 10195327269470 (each) 40195327269471 (case), Lot Numbers: 22KMB120, 22KMB121, 23EMB091, 23DMB727, 23BMD165, 23FMD066, 23GMH580, 23JMA281, 23KBV062, 24ABN126, 24DBT379, 24DBD204; 12) REF DYNJ0101314D, UDI/DI 10195327286453 (each) 40195327286454 (case), Lot Numbers: 23HDA133, 23FDA245; 13) REF DYNJ0101397M, UDI/DI 10195327295813 (each) 40195327295814 (case), Lot Numbers: 22LBL740; 14) REF DYNJ0101397N… Full codes in the FDA record24754 units
Z-0630-2025MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 77) LAPAROTOMY PACK-LF, REF DYNJ0366425N; 78) MAJOR PACK-LF, REF DYNJ0386381L; 79) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 80) LAPAROSCOPY GYN PACK, REF DYNJ05175M; 81) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 82) MINOR PACK-LF, REF DYNJ0531958S; 83) MAJOR PACK-LF, REF DYNJ0531964X; 84) LAP CHOLE PACK-LF, REF DYNJ0537278AD; 85) LAP/CHOLE PACK-LF, REF DYNJ0589896R; 86) LAP/CHOLE PACK-LF, REF DYNJ0589896S; 87) LAP/CHOLE PACK-LF, REF DYNJ0589896T; 88) LAP/CHOLE PACK-LF, REF DYNJ0589896U; 89) LAP/CHOLE PACK-LF, REF DYNJ0589896V; 90) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913K; 91) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913M; 92) LKLND LP CHL PK RFID-LF, REF DYNJ0619913N; 93) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401Q; 94) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401R; 95) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 96) MAJOR LAPAROTOMY PACK-LF, REF DYNJ0751444S; 97) MAJO; 1) REF CDS760057J, UDI/DI 10195327008963 (each) 40195327008964 (case), Lot Numbers: 22FBX954, 22FBE976; 2) REF CDS760057K, UDI/DI 10195327274368 (each) 40195327274369 (case), Lot Numbers: 23ABU244, 22LBC409, 23GBN928, 23CBO552, 23EBA183, 23JBH987; 3) REF CDS760057L, UDI/DI 10195327533373 (each) 40195327533374 (case), Lot Numbers: 23KBL294; 4) REF CDS860015W, UDI/DI 10195327349509 (each) 40195327349500 (case), Lot Numbers: 23FBP597; 5) REF CDS860016P, UDI/DI 10193489848007 (each) 40193489848008 (case), Lot Numbers: 22FBQ637; 6) REF CDS860016Q, UDI/DI 10195327209599 (each) 40195327209590 (case), Lot Numbers: 23ABM653, 22KBA835, 22JBE511; 7) REF CDS860016R, UDI/DI 10195327349479 (each) 40195327349470 (case), Lot Numbers: 23GBD634; 8) REF CDS860062R, UDI/DI 10193489852073 (each) 40193489852074 (case), Lot Numbers: 22OBE627, 22OBA906; 9) REF CDS860062S, UDI/DI 10195327140632 (each) 40195327140633 (case), Lot Numbers: 22GBS435, 22GBO814, 23ABG350, 23DBG817, 23EBQ675; 10) REF CDS860194I, UDI/DI 10193489445152 (each) 40193489445153 (case), Lot Numbers: 22GBN008, 23BBR005, 22LBJ448, 22JBH327, 23GBL900, 23GBM243, 23DBE016, 22KBK702; 11) REF CDS920080R, UDI/DI 10195327079086 (each) 40195327079087 (case), Lot Numbers: 22GBZ014, 22GBD101; 12) REF CDS920080S, UDI/DI 10195327209605 (each) 40195327209606 (case), Lot Numbers: 23ABK590, 22JBO105; 13) REF CDS920080T, UDI/DI 10195327349486 (each) 40195327349487 (case), Lot Numbers: 23EBB523; 14) REF CDS930027U, UDI/DI 10193489288537 (each) 40193489288538 (case), Lot Numbers: 22FBY534; 15) REF CDS930027V, UDI/DI 10195327241759 (each) 40195327241750 (case), Lot Numbers: 22JBR529, 22JBJ699, 23CBP730, 23ABL590, 23FBV023; 16)… Full codes in the FDA record167074 units
Z-0631-2025MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L; 1) REF DYNJ44673G, UDI/DI 10195327127473 (each) 40195327127474 (case), Lot Numbers: 23GDB181; 2) REF DYNJ49672L , UDI/DI 10195327127794 (each) 40195327127795 (case), Lot Numbers: 22GDB352, 22FDC21070 units
Z-0632-2025MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597; REF DYNJ81597, UDI/DI 10195327124007 (each) 40195327124008 (case), Lot Numbers: 22IBF254, 23BBO29944 units
Z-0633-2025MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC CDS, REF CDS984993P; 13) PLASTIC PACK, REF DYNJ00264L; 14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L; 15) OCULOPLASTY PACK-LF, REF DYNJ0252232U; 16) PLASTICS PACK, REF DYNJ02615G; 17) BREAST PBM-LF, REF DYNJ0318423M; 18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P; 19) BREAST PACK-LF, REF DYNJ0378394R; 20) BREAST PACK-LF, REF DYNJ0378394S; 21) BREAST PACK-LF, REF DYNJ0378394T; 22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K; 23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 24) ASC MAJOR PLASTIC PACK-LF, REF DYNJ0854517M; 25) ASC ENT PLASTIC PACK-LF, REF DYNJ0854650J; 26) BREAST PACK-LF, REF DYNJ0956628M; 27) BREAST PACK-LF, REF DYNJ0956628N; 28) BREAST PACK-LF, REF DYNJ0956628O; 29) AUGMENTATION #87-RF, REF DYNJ27319U; 30) AUGMENTATION #87-RF, REF DYNJ27319V; 31) PLASTICS PACK-LF, REF DYNJ36107J; 32) PLASTIC MINOR PACK, REF DYNJ37620F; 33) CHEST/BREAST PACK, REF DYNJ39118C; 34) PLASTIC BREAST PACK, REF DYNJ40620C; 35) PLASTIC BREAST PACK, REF DYNJ40620D; 36) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 37) BREAST MINOR PK RFID, REF DYNJ52409J; 38) BREAST MAJOR PACK, REF DYNJ52435J; 39) BREAST MAJOR PK RFID, REF DYNJ52435K; 40) BREAST PACK, REF DYNJ57527C; 41) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 42) BREAST PACK SSC, REF DYNJ59733A; 43) BREAST PACK, REF DYNJ60511B; 44) BREAST PACK, REF DYNJ60511F; 45) PLASTIC PACK, REF DYNJ61755B; 46) TYMPANOPLASTY, REF DYNJ63332D; 47) BREAST PACK, REF DYNJ63369D; 48) BREAST SURGERY FOAKS, REF DYNJ63577C; 49) MAJOR PLASTIC FOAKS, REF DYNJ63579C; 50) MAJOR PLASTIC PACK FAIRFAX, REF DYNJ63612C; 51) MAJOR BREAST WOMENS PACK, REF DYNJ63647C; 52) PLASTIC BASIN PACK, REF DYNJ63883B; 53) PLASTICS WOODBURN, REF DYNJ64001B; 54) BREAST PK, REF DYNJ64144B; 55) BREAST PK, REF DYNJ64144C; 56) PACK,PLASTIC, REF DYNJ65477B; 57) PACK,PLASTIC BASIC ASC, REF DYNJ65485A; 58) OSC BREAST PACK, REF DYNJ65808A; 59) CHEST/BREAST PACK, REF DYNJ66495A; 60) PLASTICS PACK, REF DYNJ66610B; 61) BREAST PACK, REF DYNJ66739B; 62) MAJOR PLASTICS PACK, REF DYNJ67968A; 63) BREAST PACK, REF DYNJ68464A; 64) FLAP PACK, REF DYNJ80179A; 65) PLASTICS PACK, REF DYNJ81797A; 66) PLASTICS PACK, REF DYNJ81811A; 67) MINOR PLASTICS PACK, REF DYNJ82196; 68) MINOR PLASTICS PACK, REF DYNJ82196A; 69) DELNOR MAJOR PLASTICS PACK, REF DYNJ82248; 70) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250; 71) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250A; 72) DELNOR AUGMENTATION PACK, REF DYNJ82265; 73) DELNOR AUGMENTATION PACK, REF DYNJ82265A; 74) AUGMENTATION PACK, REF DYNJ82279; 75) AUGMENTATION PACK, REF DYNJ82279A; 76) PLASTIC SURGERY PACK, REF DYNJ82352; 77) PLASTIC SURGERY PACK, REF DYNJ82352A; 78) FREE FLAP 2 PACK, REF DYNJ82659B; 79) FREE FLAP 1 PACK, REF DYNJ82660A; 80) FREE FLAP 1 PACK, REF DYNJ82660B; 81) FACE PACK, REF DYNJ83532; 82) BREAST RECONSTRUCTION PACK-LF, REF DYNJ83612A; 83) PLASTIC PACK, REF DYNJ83856; 84) BREAST PACK, REF DYNJ84332; 85) MAJOR PLASTIC PACK, REF DYNJ84827; 86) PLASTICS PACK, REF DYNJ84966; 87) PLASTIC PACK, REF DYNJ85702; 88) FACIAL PLASTICS FLAP PACK, REF DYNJ86031; 89) BREAST-CHEST, REF DYNJ900294K; 90) GENERAL PLASTIC-LF, REF DYNJ901738O; 91) TRAM RECONSTRUCTION-LF, REF DYNJ901753L; 92) PLASTIC UNIVERSAL, REF DYNJ901792J; 93) MID HUDSON BREAST, REF DYNJ903614C; 94) MID HUDSON BREAST, REF DYNJ903614D; 95) MID HUDSON BREAST, REF DYNJ903614F; 96) MID HUDSON PLASTICS, REF DYNJ903616F; 97) MID HUDSON PLASTICS, REF DYNJ903616G; 98) MID; 1) REF CDS983478L, UDI/DI 10195327497286 (each) 40195327497287 (case), Lot Numbers: 23JDA999, 23KDB756, 24ADA957, 24DDA553; 2) REF CDS983478M, UDI/DI 10198459000065 (each) 40198459000066 (case), Lot Numbers: 24EDB504; 3) REF CDS983493M, UDI/DI 10195327497415 (each) 40195327497416 (case), Lot Numbers: 23LDA144, 24ADA328; 4) REF CDS983496L, UDI/DI 10195327497408 (each) 40195327497409 (case), Lot Numbers: 23KDC085, 24ADB601; 5) REF CDS983496M, UDI/DI 10198459000201 (each) 40198459000202 (case), Lot Numbers: 24EDA817; 6) REF CDS983498N, UDI/DI 10198459000188 (each) 40198459000189 (case), Lot Numbers: 24EDA816; 7) REF CDS983639J, UDI/DI 10195327228149 (each) 40195327228140 (case), Lot Numbers: 22IBF012, 22IBF004, 22LBE960, 22KBK687; 8) REF CDS983639K, UDI/DI 10195327351533 (each) 40195327351534 (case), Lot Numbers: 23EBA182, 23EBN996, 23CBV828, 23FBP157, 23FBH151; 9) REF CDS984267J, UDI/DI 10193489288872 (each) 40193489288873 (case), Lot Numbers: 22GBR052, 22FBG539, 22KBU660, 23ABL613, 23DBD827; 10) REF CDS984993N, UDI/DI 10195327031114 (each) 40195327031115 (case), Lot Numbers: 22EBV339; 11) REF CDS984993O, UDI/DI 10195327175764 (each) 40195327175765 (case), Lot Numbers: 22GBF349, 22JBJ441, 23BBV017, 23EBN595, 23IBU110, 23GBE740, 23GBE766, 23IBC614, 23LBC779, 23KBH710; 12) REF CDS984993P, UDI/DI 10195327588007 (each) 40195327588008 (case), Lot Numbers: 24ABH482, 24DBD860; 13) REF DYNJ00264L, UDI/DI 10193489942019 (each) 40193489942010 (case), Lot Numbers: 22IMH644, 22EMF495, 23AMB776, 22FMD650, 23CMA570, 22KME942; 14) REF DYNJ0101536L, UDI/DI 10195327333041 (each) 40195327333042 (case), Lot Numbers: 23IMB288; 15) REF DYNJ0252232U, UDI/DI 10193489954111 (each)… Full codes in the FDA record25877 units
Z-0634-2025MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, REF DYNJ0867331G; 6) TOTAL KNEE BASIN B PACK-LF, REF DYNJ0867555L; 7) ST. ANNE'S MINOR BASIN PACK, REF DYNJ24622K; 8) ST. ANNE'S MAJOR BASIN SET UP, REF DYNJ24628M; 9) MAJOR BASIN SET, REF DYNJ41285B; 10) BASIN PACK, REF DYNJ50123D; 11) MAJOR BASIN TRAY, REF DYNJ54461F; 12) MAJOR BASIN TRAY, REF DYNJ54461G; 13) MAJOR BASIN TRAY, REF DYNJ54461I; 14) TR-MINOR KIT-LF, REF DYNJ54801F; 15) TR-MAJOR KIT-LF, REF DYNJ54802I; 16) MAJOR BASIN PACK, REF DYNJ59816A; 17) SINGLE BASIN PACK ST VINCENT, REF DYNJ60529D; 18) BASIN PACK, REF DYNJ60812B; 19) BASIN PACK SH, REF DYNJ60812C; 20) PLASTIC BASIN PACK, REF DYNJ63883C; 21) MINOR PACK, REF DYNJ63961D; 22) OSC BREAST PACK, REF DYNJ65808B; 23) OSC BASIN PACK, REF DYNJ68217A; 24) DELNOR VASCULAR BASIN PACK, REF DYNJ82257; 25) DELNOR BASIN PACK, REF DYNJ82267; 26) STAZ MAJOR BASIN, REF DYNJ909785; 27) LUMBAR, REF DYNJ909923; 1) REF DYNJ0619907I, UDI/DI 10195327239480 (each) 40195327239481 (case), Lot Numbers: 22IMG033; 2) REF DYNJ0619907K, UDI/DI 10195327295905 (each) 40195327295906 (case), Lot Numbers: 22LME111; 3) REF DYNJ0619907L, UDI/DI 10195327333119 (each) 40195327333110 (case), Lot Numbers: 23JBH171, 23HBV761, 23FMI052; 4) REF DYNJ06966M, UDI/DI 10195327349059 (each) 40195327349050 (case), Lot Numbers: 23EBR799, 23IBI141, 23KBC445, 23LBJ670; 5) REF DYNJ0867331G, UDI/DI 10195327118433 (each) 40195327118434 (case), Lot Numbers: 22EDA376, 22FDA407; 6) REF DYNJ0867555L, UDI/DI 10195327202613 (each) 40195327202614 (case), Lot Numbers: 23DDB147; 7) REF DYNJ24622K, UDI/DI 10195327109127 (each) 40195327109128 (case), Lot Numbers: 23ABN514, 22EBS282, 22EBE400, 23CBV810, 23CBH097, 23EBT659; 8) REF DYNJ24628M, UDI/DI 10195327109134 (each) 40195327109135 (case), Lot Numbers: 22FLA375, 22DLA993, 22ILA590, 23GLA918, 23FLA366, 23DLA800, 23BLA536, 22JLA323, 23CLB087; 9) REF DYNJ41285B, UDI/DI 10195327515546 (each) 40195327515547 (case), Lot Numbers: 23KBF131; 10) REF DYNJ50123D, UDI/DI 10195327201999 (each) 40195327201990 (case), Lot Numbers: 22KBI121, 22KBI122, 23CBT112, 23EBB417; 11) REF DYNJ54461F, UDI/DI 10195327155728 (each) 40195327155729 (case), Lot Numbers: 22IMA730, 22LMG820, 23EMB339, 23DMD912, 23HMG790, 23HMC613, 23GMF360, 23IMH847; 12) REF DYNJ54461G, UDI/DI 10195327543570 (each) 40195327543571 (case), Lot Numbers: 23KMA747, 23KBS302, 24ABI360; 13) REF DYNJ54461I, UDI/DI 10195327613730 (each) 40195327613731 (case), Lot Numbers: 24BBG122, 24ABS064, 24DBG019; 14) REF DYNJ54801F, UDI/DI 10195327450861 (each) 40195327450862 (case), Lot Numbers: 23HDC012; 15) REF DYNJ54802I, UDI/DI 10195327450878 (each) 40195327450879 (case), Lot Numbers: 23FDC386, 23IDA377; 16) REF DYNJ59816A, UDI/DI 10195327331573 (each) 40195327331574 (case), Lot Numbers: 23CBV819, 23EBF888; 17) REF DYNJ60529D, UDI/DI 10195327523411 (each) 40195327523412 (case), Lot Numbers: 23JMH503; 18) REF DYNJ60812B, UDI/DI 10195327454630 (each) 40195327454631 (case), Lot Numbers: 23HBL174; 19) REF DYNJ60812C, UDI/DI 10195327521226 (each) 40195327521227 (case), Lot Numbers: 23KBE930, 23JBN323, 23LBN436; 20) REF DYNJ63883C, UDI/DI 10195327221829 (each) 40195327221820 (case), Lot Numbers: 23IDA838, 23GDA969, 23ADA553, 22JDC142, 23KDA710, 24ADB347, 23CDB848, 23EDA013, 24CDA880; 21) REF DYNJ63961D, UDI/DI 10195327428877 (each) 40195327428878 (case), Lot Numbers: 23HDC162, 23GDB814, 23JDA825, 24BDA028, 24DDA624; 22) REF DYNJ65808B, UDI/DI 10195327273552 (each) 40195327273553 (case), Lot Numbers: 23AMI184, 23AMA558; 23) REF DYNJ68217A, UDI/DI 10195327352523 (each) 40195327352524 (case), Lot Numbers: 23CME053, 23FMG407; 24) REF DYNJ82257, UDI/DI 10195327181659 (each) 40195327181650 (case), Lot Numbers: 23IMA316; 25) REF DYNJ82267, UDI/DI 10195327182229 (each) 40195327182220 (case), Lot Numbers: 23GDB214, 23IDC201; 26) REF DYNJ909785, UDI/DI 10195327475819 (each) 40195327475810 (case), Lot Numbers: 23HBU592, 23IBN694; 27) REF DYNJ909923, UDI/DI 10195327504533 (each) 40195327504534 (case), Lot Numbers: 23LMB294, 24BMC91914388 units
Z-0635-2025Refer to RES or lead review memo for complete list of affected reference/catalog numbers; 1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 40193489402774 (case), Lot Numbers: 22GBT396; 15) REF CDS983914K, UDI/DI 10193489402698 (each) 40193489402699 (case), Lot Numbers: 22EBA061, 22DBU743, 22GBI220; 16) REF CDS984599F, UDI/DI 10193489486148 (each) 40193489486149 (case), Lot Numbers: 22EMH743, 22HMA205, 22GMB332, 22KMF120, 22KMF139, 22HMF967, 23FME358, 23AMI307, 22LMF801, 23GMB934, 23KMF368, 23LMC668; 17) REF CDS984600F, UDI/DI 10193489486100 (each) 40193489486101 (case), Lot Numbers: 22JME533, 22HMH038, 23FMA360, 23EMI198, 23AMJ617, 23AMG705, 22LMI741, 23KMJ525, 23JMK211; 18) REF CDS984640G, UDI/DI 10195327435806 (each) 40195327435807 (case), Lot Numbers: 23IBD455, 23FBU659, 23JBF568, 23JBS933; 19) REF CDS984897J, UDI/DI 10193489983845 (each) 40193489983846 (case), Lot Numbers: 22KBM268; 20) REF CV6222T, UDI/DI 10193489314625 (each) 40193489314626 (case), Lot Numbers: 22ILA422, 23ILA216, 24ALA281, 23FLA764, 23DLA119; 21) REF DYNJ0101232F, UDI/DI 10195327028862 (each) 40195327028863 (case), Lot Numbers: 23DMI192, 23JBC628; 22) REF DYNJ0101285F, UDI/DI 10195327286569 (each) 40195327286560 (case), Lot Numbers: 23JDA016; 23) REF DYNJ0101339K, UDI/DI 10195327286583 (each) 40195327286584 (case), Lot Numbers: 23FDC341, 23EDC145, 23DDB460; 24) REF DYNJ0101435I, UDI/DI 10195327239473 (each) 40195327239474 (case), Lot Numbers: 23HMC631; 25) REF DYNJ0105614I, UDI/DI 10889942854165 (each) 40889942854166 (case), Lot Numbers: 23GBI709; 26) REF DYNJ0113967O, UDI/DI 10889942854189 (each) 40889942854180 (case), Lot Numbers: 23HBE512, 24ABO593; 27) REF DYNJ0161854D, UDI/DI 10195327304324 (each) 40195327304325 (case), Lot Numbers: 23DDB024, 23BDA412; 28) REF DYNJ0161949C, UDI/DI 10195327304331 (each) 40195327304332 (case), Lot Numbers: 22LDA230; 29) REF DYNJ01928K, UDI/DI 10195327491574 (each) 40195327491575 (case), Lot Numbers: 23KBI399; 30) REF DYNJ0259893T, UDI/DI 10195327356750 (each) 40195327356751 (case), Lot Numbers: 23DMA326; 31) REF DYNJ0282079U, UDI/DI 10195327589394 (each) 40195327589395 (case), Lot Numbers: 24ABX980, 24ABH203, 24DBV818, 24CBT374; 32) REF DYNJ0325443N, UDI/DI 10195327376055 (each) 40195327376056 (case), Lot Numbers: 23KBD218, 23GBI710; 33) REF DYNJ0378367R, UDI/DI 10195327494926 (each) 40195327494927 (case), Lot Numbers: 23JBD244, 23KBD947; 34) REF DYNJ0378388Q, UDI/DI 10195327500665 (each) 40195327500666 (case), Lot Numbers: 23JBV566; 35) REF DYNJ0426069L, UDI/DI 10195327058029 (each) 40195327058020 (case), Lot Numbers: 22ELB112, 22EMI117; 36) REF DYNJ0426069M, UDI/DI 10195327205751 (each) 40195327205752 (case), Lot Numbers: 23AMH835, 22KME294, 23BMH216; 37) REF DYNJ0451468O, UDI/DI 10195327133993 (each) 40195327133994 (case), Lot Numbers: 22FBS258, 22EBH139, 22IBG605, 22KBD097, 23FBL656, 23BBH595, 23HBA302, 23CBB976, 23GBI183, 23CBP369, 23JBX426; 38) REF DYNJ0488631K, UDI/DI 10195327045951 (each) 40195327045952 (case), Lot Numbers: 22EBS985; 39) REF DYNJ0488631L, UDI/DI 10195327268831 (each) 40195327268832 (case), Lot Numbers: 22LBK638, 23CBM512, 23GBO248, 23IBS187, 23KBA400; 40) REF DYNJ0506906S, UDI/DI 10195327356774 (each) 40195327356775 (case), Lot Numbers: 23CMH763; 41) REF DYNJ0516935J, UDI/DI 10195327049720 (each) 40195327049721 (case), Lot Numbers: 22FMA111, 22LMF274; 42) REF DYNJ0516935K, UDI/DI 10195327376864 (each) 40195327376865 (case), Lot Numbers: 23DME703, 23HMI006; 43) REF DYNJ0519294K, UDI/DI 10195327084851 (each) 40195327084852 (case), Lot Numbers: 22FMG362, 22GMC619, 22FMF113, 22EMG243, 22HMG065, 22LMA637, 23CMA602, 23DMB986; 44) REF DYNJ0531958Q, UDI/DI 10195327124670 (each) 40195327124671 (case), Lot Numbers: 22GMH926; 45) REF DYNJ0531958R, UDI/DI 10195327248048 (each) 40195327248049 (case), Lot Numbers: 22JMB533, 23CMB334; 46) REF DYNJ0531958T, UDI/DI 10198459006685 (each) 40198459006686 (case), Lot Numbers: 24FMJ982; 47) REF DYNJ0531964U, UDI/DI 10195327124762 (each) 40195327124763 (case), Lot Numbers: 22EMD975, 22EMA812; 48) REF DYNJ0531964V, UDI/DI 10195327216634 (each) 40195327216635 (case), Lot Numbers: 22HMG182, 22HMB122; 49)… Full codes in the FDA record102561 units
Z-0636-2025MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B; REF DYNJ52141B, UDI/DI 10195327028459 (each) 40195327028450 (case), Lot Numbers: 23FMA347, 23JBS20036 units
Z-0637-2025MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D; 1) REF CDS983465N, UDI/DI 10195327497309 (each) 40195327497300 (case), Lot Numbers: 24CDB460, 24BDA880, 23KDB948; 2)REF CDS983465N, UDI/DI 10195327699987 (each) 40195327699988 (case), Lot Numbers: 24EDB092, 24EDA519; 3) REF DYNJ63331D, UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case), Lot Numbers: 23LME440, 23HMI168, 23KMD370486 units
Z-0638-2025MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667; 1) REF DYNJ80686A, UDI/DI 10195327560645 (each) 40195327560646 (case), Lot Numbers: 24CBR604, 24CBA831; 2) REF DYNJ84667, UDI/DI 10195327396329 (each) 40195327396320 (case), Lot Numbers: 23KBO98066 units
Z-0639-2025MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672; REF DYNJ82672, UDI/DI 10195327203030 (each) 40195327203031 (case), Lot Numbers: 23HMI04830 units
Z-0640-2025MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 13) NEURO-ORTHO EXTRAS, REF DYNJ44882L; 14) NEURO PACK, REF DYNJ57785B; 15) NEURO PACK, REF DYNJ60825B; 16) CHRISTUS MC NEURO PACK, REF DYNJ61157C; 17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C; 18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C; 19) AFCH SHUNT, REF DYNJ63317C; 20) NEURO SPINE PK, REF DYNJ63319D; 21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D; 22) DBS PACK, REF DYNJ63322A; 23) NEURO LAM, REF DYNJ64188B; 24) PACK,V-P SHUNT, REF DYNJ65472B; 25) NEURO PK, REF DYNJ66735A; 26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B; 27) NEURO PACK, REF DYNJ68558A; 28) NEURO PACK, REF DYNJ69019C; 29) VP SHUNT, REF DYNJ81866A; 30) VP SHUNT, REF DYNJ81866B; 31) VP SHUNT, REF DYNJ81866C; 32) NEURO PACK, REF DYNJ84058A; 33) NEURO, REF DYNJ900420O; 34) CRANIO / NEURO / SPINE, REF DYNJ901072G; 35) CRANIO / NEURO / SPINE, REF DYNJ901072I; 36) LAMINECTOMY, REF DYNJ903870F; 37) MINOR NEURO, REF DYNJ904859C; 38) MINOR NEURO, REF DYNJ904859D; 39) MINOR NEURO, REF DYNJ904859F; 40) NEURO, REF DYNJ904861B; 41) NEURO, REF DYNJ904861D; 42) NEURO, REF DYNJ904861F; 43) NEURO, REF DYNJ904861G; 44) KIT V P SHUNT, REF DYNJ908835A; 45) GENERAL NEURO, REF DYNJ909744; 84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers: 22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065; 2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers: 22LMA225, 23EME852, 23DME052; 3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23FMI343, 4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105; 5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers: 22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472; 6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers: 23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557; 7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23GMC512, 23GMC697; 8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers: 23JMH534; 9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers: 22EBF993, 22GBB271, 22FBF013; 10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers: 22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780; 11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers: 23IDC125, 23EDB879, 23DDB255, 23GDA826; 12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 22EBN168, 22EBB079, 22HBY426, 22EBB077, 22IBS173, 22JBV775, 22JBW872, 23ABK720, 23ABB556; 13) REF DYNJ44882L, UDI/DI 10195327127725 (each) 40195327127726 (case), Lot Numbers: 22FDA475, 22LDA151, 22KDA751, 22HDA703, 23BDC150, 23ADB774, 22IDB866; 14) REF DYNJ57785B, UDI/DI 10195327072643 (each) 40195327072644 (case), Lot Numbers: 22GMF726, 22FMD430, 23AMF372, 23HMD358, 23JME934; 15) REF DYNJ60825B, UDI/DI 10195327521301 (each) 40195327521302 (case), Lot Numbers: 23KBE951, 23JBH391; 16) REF DYNJ61157C, UDI/DI 10195327470234 (each) 40195327470235 (case), Lot Numbers: 23IBP298; 17) REF DYNJ61168C, UDI/DI 10195327470197 (each) 40195327470198 (case), Lot Numbers: 23IBQ047; 18) REF DYNJ61174C, UDI/DI 10195327470203 (each) 40195327470204 (case), Lot Numbers: 23ILA859, 23HLB095; 19) REF DYNJ63317C, UDI/DI 10195327273446 (each) 40195327273447 (case), Lot Numbers: 23AMG481, 23BMC514, 23JMG245; 20) REF DYNJ63319D, UDI/DI 10195327402167 (each) 40195327402168 (case), Lot Numbers: 23FMG396, 23KMI427; 21) REF DYNJ63321D, UDI/DI 10195327404154 (each) 40195327404155 (case), Lot Numbers: 23GMH332; 22) REF DYNJ63322A, UDI/DI 10193489958058 (each) 40193489958059 (case), Lot Numbers: 22FBX778; 23) REF DYNJ64188B, UDI/DI 10195327279721 (each) 40195327279722 (case), Lot Numbers: 22LBE618, 23BBD435, 23ABJ723, 22LBP476, 23FBR198, 23JBE272; 24) REF DYNJ65472B, UDI/DI 10195327303396 (each) 40195327303397 (case), Lot Numbers: 23AMI025, 22LMJ219, 23DMB323, 23JMJ552; 25) REF DYNJ66735A, UDI/DI 10195327504755 (each) 40195327504756 (case), Lot Numbers: 23KBC296, 23JBT150, 23KBL436, 24DBV652; 26) REF DYNJ66766B, UDI/DI 10195327286286 (each) 40195327286287 (case), Lot Numbers: 23HMH943; 27) REF DYNJ68558A, UDI/DI 10193489994926 (each) 40193489994927 (case), Lot Numbers: 22GBT930, 22JBN310, 22LBN425, 22LBE068, 23ABD982, 23FBG228, 23IBG968, 23GBE570; 28) REF DYNJ69019C, UDI/DI 10195327436674 (each) 40195327436675 (case), Lot Numbers: 23GBE293, 23JBL407, 23LBQ035; 29) REF DYNJ81866A, UDI/DI 10195327216467 (each) 40195327216468 (case), Lot Numbers: 22IMF886, 22LMF365; 30) REF DYNJ81866B, UDI/DI 10195327302252 (each) 40195327302253 (case), Lot Numbers: 23BMI434, 23BMC486; 31) REF DYNJ81866C, UDI/DI 10195327417109 (each) 40195327417100 (case), Lot Numbers: 23GMA996, 23HMF910, 23JMC277, 24BMA973, 24AMH042, 23KMF115, 23LMA617, 24EMC255, 24CMH446; 32) REF DYNJ84058A, UDI/DI 10195327358013 (each) 40195327358014 (case), Lot Numbers: 23DBB749; 33)… Full codes in the FDA record12847 units
Z-0641-2025MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B; 1) REF CDS984955M, UDI/DI 10195327313302 (each) 40195327313303 (case), Lot Numbers: 23CBU078, 23HBG687, 23IBF280; 2) REF CDS984995M, UDI/DI 10195327043766 (each) 40195327043767 (case), Lot Numbers: 22GBA249, 23ABF616, 23ABF770, 23EBG938, 23CBD779, 23GBH707, 23KBU446, 23IBE467; 3) REF DYNJ0826768P, UDI/DI 10193489265699 (each) 40193489265690 (case), Lot Numbers: 22FMC589, 22DMI812, 23AMG530, 23FMI241, 23HMI199, 23JMF359; 4) REF DYNJ59081C, UDI/DI 10195327200404 (each) 40195327200405 (case), Lot Numbers: 22HBC733, 22LBL495, 23CBU862, 23BBF607, 23FBI028, 23EBU222, 23BBS154, 23GBI132, 23KBA604, 23JBE732; 5) REF DYNJ65807C, UDI/DI 10195327273668 (each) 40195327273669 (case), Lot Numbers: 23AMH550, 23DMD460, 23IMG365; 6) REF DYNJ67757B, UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 22HBH633, 22KBS878, 22JBF053, 23CBC829, 23BBH3341952 units
Z-0642-2025MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J; 1) REF DYNJ0531985R, UDI/DI 10195327216405 (each) 40195327216406 (case), Lot Numbers: 22HMF853, 23CMA603, 22LMG691; 2) REF DYNJ0843760I, UDI/DI 10195327365141 (each) 40195327365142 (case), Lot Numbers: 23DDA645; 3) REF DYNJ0843760J, UDI/DI 10195327491369 (each) 40195327491360 (case), Lot Numbers: 23JDA821336 units
Z-0643-2025MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;; 85OHD, 1) REF CDS760059I, UDI/DI 10195327009526 (each) 40195327009527 (case), Lot Numbers: 22KBT168, 22GBJ110, 22FBO228, 22FBN206, 23ABM526; 2) REF CDS920099S, UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 22EBA153, 23HBS831, 23GBT006, 23ABF835, 23ABE852, 23ABC459, 22IBE827, 22GBP098; 3) REF CDS980998L, UDI/DI 10193489232837 (each) 40193489232838 (case), Lot Numbers: 23HBS764, 24CBA346, 24BBO669; 4) REF CDS982128P, UDI/DI 10195327491659 (each) 40195327491650 (case), Lot Numbers: 23JBV057; 5) REF CDS984262N, UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 23ABN752, 23ABH001, 23CBU637, 23EBG216, 23FBL899; 6) REF CDS984900M, UDI/DI 10195327265670 (each) 40195327265671 (case), Lot Numbers: 23EBA735; 7) REF CDS984900N, UDI/DI 10195327448417 (each) 40195327448418 (case), Lot Numbers: 23JBT539, 24ABT539; 8) REF DYNJ0101304G, UDI/DI 10195327351663 (each) 40195327351664 (case), Lot Numbers: 23GDA822, 23CDA336; 9) REF DYNJ0347372J, UDI/DI 10195327555245 (each) 40195327555246 (case), Lot Numbers: 24CBN143, 24DBI923; 10) REF DYNJ17454N, UDI/DI 10195327491604 (each) 40195327491605 (case), Lot Numbers: 23JBR958; 11) REF DYNJ33592I, UDI/DI 10195327469559 (each) 40195327469550 (case), Lot Numbers: 23IDC293; 12) REF DYNJ38844N, UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23DBB947, 23CBN366, 23EBW814, 23BBD619, 23DBI585; 13) REF DYNJ42792D, UDI/DI 10195327653514 (each) 40195327653515 (case), Lot Numbers: 24CBA980; 14) REF DYNJ43770L, UDI/DI 10193489989991 (each) 40193489989992 (case), Lot Numbers: 22IBC524, 22JBT938, 23GBN441, 23KBE916, 23JBJ792, 24ABW049, 24BBJ418, 23DBB305, 22LBI806, 22LBI807, 23ABM291, 23EBT683, 23DBM687, 24CBK840, 24CBA672; 15) REF DYNJ43778L, UDI/DI 10193489990133 (each) 40193489990134 (case), Lot Numbers: 22EBR178, 22DBI437, 22GBK246, 23BBG028, 23FBD832, 23DBB308, 23GBN442, 23LBN691, 24BBK830; 16) REF DYNJ43782K, UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Numbers: 22GBK022, 22JBM498, 22IBD372, 22KBO079, 23JBN680, 23KBK083, 24BBM541, 24ABN836, 24EBE613; 17) REF DYNJ43862J, UDI/DI 10193489990157 (each) 40193489990158 (case), Lot Numbers: 22LLA203, 22JLB142, 22ILA238, 22KLA975, 23ALA636, 23DLA332, 23BLA068, 23FLA225, 23HLA685, 23GLB210, 23KLA370, 23GLA459, 24BLA720, 24ALA170, 23JLA444, 23ILA920, 24DLA220; 18) REF DYNJ44863O, UDI/DI 10195327127619 (each) 40195327127610 (case), Lot Numbers: 22HDB157; 19) REF DYNJ44864S, UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 22GBA089, 23DBR620, 22HBY159, 22EBC670, 23BBV092; 20) REF DYNJ44876L, UDI/DI 10195327127695 (each) 40195327127696 (case), Lot Numbers: 22HDB217; 21) REF… Full codes in the FDA record13057 units
Z-0644-2025MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A; 1) REF DYNJ16826O, UDI/DI 10195327412067 (each) 40195327412068 (case), Lot Numbers: 23FMC064; 2) REF DYNJ64432, UDI/DI 10193489814255 (each) 40193489814256 (case), Lot Numbers: 22CDC116, 22DDC463, 22JDA234, 22KDA275, 23BDA297, 23DDC249, 23FDB680; 3) REF DYNJ906909A, UDI/DI 10195327303532 (each) 40195327303533 (case), Lot Numbers: 23DBD597, 23DBE346, 23ABE857, 23KBH128, 23IBC034, 24ABT698828 units
Z-0645-2025MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP; 85OHM 1) REF CDS820075V, UDI/DI 10193489846973 (each) 40193489846974 (case), Lot Numbers: 22GBP851; 2) REF CDS820075W, UDI/DI 10195327209797 (each) 40195327209798 (case), Lot Numbers: 22HBH009, 23ABB066, 22JBX603, 22JBX483, 23ABM869, 22LBB096, 23EBB528, 23FBH057; 3) REF CDS980774M, UDI/DI 10193489383713 (each) 40193489383714 (case), Lot Numbers: 22JBT027, 23ABE914, 22KBE813, 23ABR052, 23GBL705, 24ABK006, 23JBQ162, 23LBT739, 23LBT825; 4) REF CDS981322AB, UDI/DI 10193489929997 (each) 40193489929998 (case), Lot Numbers: 22DBS923, 23EBE751, 23BBE438, 23HBS136; 5) REF CDS981322AC, UDI/DI 10195327539481 (each) 40195327539482 (case), Lot Numbers: 23LBJ448, 23LBJ388, 24BBF433, 24DMH817; 6) REF CDS982398I, UDI/DI 10195327029449 (each) 40195327029440 (case), Lot Numbers: 22HBF545, 22IBC664, 22JBL415, 22LBH995, 23BBS835, 23LBA643, 23JBV944, 23IBE632, 23HBJ717, 23EBP485, 24ABO332, 23FBS672, 24BBK936, 24EBC031, 24DBD943, 24CBU322, 24GBD705; 7) REF CDS983450L, UDI/DI 10193489372335 (each) 40193489372336 (case), Lot Numbers: 23ABF826, 23BBG537, 22FBS278, 22KBE444, 23JBR792; 8) REF CDS983869J, UDI/DI 10195327457617 (each) 40195327457618 (case), Lot Numbers: 23HDA541; 9) REF CDS984261J, UDI/DI 10195327139629 (each) 40195327139620 (case), Lot Numbers: 22IBF149, 23EBG169, 23CBE760, 22LBJ360, 22KBS546, 22KBS547; 10) REF CDS984516L, UDI/DI 10195327338626 (each) 40195327338627 (case), Lot Numbers: 23FDA887, 23HDB446, 23LDA038, 23JDB032, 23IDB803, 24ADA525, 23LDB093; 11) REF CDS984516M, UDI/DI 10195327629847 (each) 40195327629848 (case), Lot Numbers: 24BDB731, 24BDA997; 12) REF CDS984902K, UDI/DI 10195327156923 (each) 40195327156924 (case), Lot Numbers: 22LBH577, 23KBB878, 23HBU537… Full codes in the FDA record58765 units
Z-0646-2025MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837; 85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers: 24BBQ489, 23KBP697; 2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers: 22LDA249, 23CDB670, 23JDA480, 23IDA660; 3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers: 24ADA431, 24BDB524; 4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers: 24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697; 5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 22LDB323, 22LDC130, 23CDA546; 6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers: 23IBT540; 7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers: 22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599; 8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers: 22FMH645, 22HMF692; 9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers: 23DMD053; 10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers: 23FMC422; 11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 22EBR089, 23ABM013, 23CBX286; 12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers: 23JDA425, 23GDB694, 23JDA783; 13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers: 22HMF864, 23EMB913; 14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers: 23LMC975, 23LMC305, 24AMC175, 23FMD871; 15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers: 23IBR215; 16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers: 22IDA312, 22LDB966; 17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23ADA450, 23CDC113, 23CDA613, 23BDA189; 18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315; 19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 22KDB784, 22LDA872, 22LDB908, 23DDA086; 20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 22FBN014, 22LBP709, 23DBJ770, 23CBF613; 21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers: 23IBN858; 22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers: 22DBL296, 22FBS033; 23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers: 22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757; 24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23ABQ738; 25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers: 22GBY195, 22GBO568; 26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers: 23HMI516; 27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers: 23JMG567; 28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers: 23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601; 29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers: 22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068; 30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers: 22GBT650, 23DBA294, 23EBG706; 31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers: 22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389; 32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers: 23GBM311; 33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers… Full codes in the FDA record3452 units
Z-0647-2025MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D; 1) REF CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI/DI 10195327451295 (each) 40195327451296 (case), Lot Numbers: 23JBF512, 23IBQ647; 3) REF CDS985431L, UDI/DI 10195327527273 (each) 40195327527274 (case), Lot Numbers: 24ABA205, 24ABW239, 24ABV349, 24CBR704, 24EBP485; 4) REF DYNJ44153G, UDI/DI 10195327412623 (each) 40195327412624 (case), Lot Numbers: 23KBB932; 5) REF DYNJ60924C, UDI/DI 10195327470333 (each) 40195327470334 (case), Lot Numbers: 23JBF913; 6) REF DYNJVB1280C, UDI/DI 10195327173951 (each) 40195327173952 (case), Lot Numbers: 23ELB178, 23CLA196, 23BLA668, 23BLA272; 7) REF DYNJVB1280D, UDI/DI 10195327482114 (each) 40195327482115 (case), Lot Numbers: 24CLA257, 23LLA915, 24CLA715, 24BLA712;478 units
Z-0648-2025MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A; 1) REF DYNJ27466S, UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23DBA280; 2) REF DYNJ41207C, UDI/DI 10195327353063 (each) 40195327353064 (case), Lot Numbers: 23GMD059, 23KMH083; 3) REF DYNJ43147G, UDI/DI 10195327167257 (each) 40195327167258 (case), Lot Numbers: 22FBX412, 22FBS940; 4) REF DYNJ63329D, UDI/DI 10193489958065 (each) 40193489958066 (case), Lot Numbers: 22EBR487, 22EBC473; 5) REF DYNJ63329F, UDI/DI 10195327270414 (each) 40195327270415 (case), Lot Numbers: 23GMC980, 23LME454, 23IME156; 6) REF DYNJ64138B, UDI/DI 10193489355284 (each) 40193489355285 (case), Lot Numbers: 22FME241; 7) REF DYNJ65808C, UDI/DI 10195327369064 (each) 40195327369065 (case), Lot Numbers: 23KMF753, 23FMG930; 8) REF DYNJ81798A, UDI/DI 10195327515898 (each) 40195327515899 (case), Lot Numbers: 24CBM729, 24CBC467; 9) REF DYNJ902256C, UDI/DI 10195327089368 (each) 40195327089369 (case), Lot Numbers: 22FDA445, 22HDA810, 23CDB064, 23HDB222, 23IDB778, 23FDB836; 10) REF DYNJ909065, UDI/DI 10195327260019 (each) 40195327260010 (case), Lot Numbers: 23CMB048, 23CMA495; 11) REF DYNJ909065A, UDI/DI 10195327460648 (each) 40195327460649 (case), Lot Numbers: 24IME711, 24HME507; 12) REF DYNJVB91043A, UDI/DI 10195327309541 (each) 40195327309542 (case), Lot Numbers: 22LDB968, 23JDC086, 23KDB345, 23FDA062, 24DDB815, 24FDB4701921 units
Z-0649-2025MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425; 86OJF 1) REF CDS780112J, UDI/DI 10195327009663 (each) 40195327009664 (case), Lot Numbers: 22FBF455, 23CBH389, 23FBO500; 2) REF CDS780119V, UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 22KBN442, 22HBO015, 23ABF941, 23DBE182, 23BBQ326; 3) REF CDS780147N, UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23DBT165, 22JBU233, 23BBJ852; 4) REF CDS780148Q, UDI/DI 10193489202939 (each) 40193489202930 (case), Lot Numbers: 22JBL294; 5) REF CDS780148R, UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23CBE921, 22LBL862, 23EBA185, 23EBU780; 6) REF CDS920027W, UDI/DI 10193489946956 (each) 40193489946957 (case), Lot Numbers: 22GBL731; 7) REF CDS920027X, UDI/DI 10195327241742 (each) 40195327241743 (case), Lot Numbers: 22JBF953; 8) REF CDS920027Y, UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23CBI608, 23CBF425; 9) REF CDS940047AF, UDI/DI 10195327243890 (each) 40195327243891 (case), Lot Numbers: 23DDC114, 23FDA378, 23IDA521, 23HDB417; 10) REF CDS940047AG, UDI/DI 10195327516710 (each) 40195327516711 (case), Lot Numbers: 23KDA158; 11) REF CDS940048AF, UDI/DI 10195327150259 (each) 40195327150250 (case), Lot Numbers: 22EDB749; 12) REF CDS940048AG, UDI/DI 10195327241896 (each) 40195327241897 (case), Lot Numbers: 22IDA258, 23CDB146, 23IDA944, 23HDA534; 13) REF CDS940048AI, UDI/DI 10195327516703 (each) 40195327516704 (case), Lot Numbers: 23KDA886; 14) REF CDS940072W, UDI/DI 10193489288544 (each) 40193489288545 (case), Lot Numbers: 22DBN494; 15) REF CDS940072Y, UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23EBG408, 23EBE750; 16) REF CDS940823AB, UDI/DI 10193489883282 (each) 40193489883283… Full codes in the FDA record252162 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number and lot number on the product to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Oct 9, 202412. FDA classified it Class II: Dec 5, 202423. Published in FDA’s Enforcement Report: Dec 11, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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Keep exploring

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-0632-2025 (October 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0632-2025 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA