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Unrated Medical device recall · FDA · Published August 16, 2023

Cardinal Health Procedure Packs Recall: Risk of Contaminated Surgical Components

Cardinal Health recalls specific surgical procedure packs due to potential contamination in recalled components. Affected packs contain equipment drapes, table covers, and surgical room turnover kits. Consumers should contact the manufacturer for details.

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

🇺🇸 FDA recall #Z-0090-2024Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling certain surgical procedure packs that contain equipment drapes, table covers, and surgical room turnover kits. These components may be contaminated, posing a risk to patient safety during surgeries. Read more at govinfonow.com/recall/57469-cardinal-health-procedure-packs-recall-risk-of-contaminated-surgical-components.

Source Summary by GovInfoNow · govinfonow.com/recall/57469-cardinal-health-procedure-packs-recall-risk-of-contaminated-surgical-components · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0090-2024

Cite this page

“Cardinal Health Procedure Packs Recall: Risk of Contaminated Surgical Components.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57469-cardinal-health-procedure-packs-recall-risk-of-contaminated-surgical-components. Based on FDA recall #Z-0090-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0090-2024%22&limit=1).

Cardinal Health 200, LLC recalled Procedure packs containing recalled components, according to the FDA on August 16, 2023. The hazard involves equipment drapes and surgical room turnover kits with potential contamination risks.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile
  • Lot #81461
  • Expiration dates: 6/1/2024 and 9/1/2024
  • UDI-DI: 10195594542795

The hazard

The packs contain recalled components, specifically equipment drapes, table covers, and surgical room turnover (SRT) kits. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 58 other recalls on record since 2017-06-27. Other recent recalls of similar products include Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), Presource Convenience Kits (2026-08-10), and Presource Packs with Contaminated Wipes (2026-07-29).

How to tell if you have this one

Check for the product name 'Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.' Look for lot numbers 81461 with expiration dates 6/1/2024 or 9/1/2024.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 10 products

All 10 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 distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Recall numberProduct, codes & lots
Z-0083-2024Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.; (1) Cat. SBAHFPTAS2 - Lot #900813, exp. 1/1/2025, UDI-DI 10195594810351; and (2) Cat. SNE37ANMOF - Lot #32724, exp. 4/1/2025, UDI-DI 10195594576080.
Z-0084-2024Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.; (1) Cat. PC71EXOU7 - Lot #916915, Exp. 5/1/2024, UDI-DI 10195594873332; (2) Cat. PVOCMVBLC - Lot #922978, Exp. 10/1/2024; and Lot #922978, Exp. 7/1/2024, UDI-DI 10195594763183; (3) Cat. PVRMMVAOH7 - Lot #923996, Exp. 1/1/2024, UDI-DI 10195594892777; (4) Cat. PV30VPUHA - Lot #898892, Exp. 2/1/2024, UDI-DI 10195594485894; (5) Cat. SANOCCPDM2 - Lot #920122, Exp. 6/1/2025, UDI-DI 10195594882273; (6) Cat. SAN1FPMULM - Lot #929016, Exp. 6/1/2024, UDI-DI 10195594712938; (7) Cat. SAN11OADMM - Lot #985859, Exp. 11/1/2025, UDI-DI 10195594553562; (8) Cat. SAN13DILCO - Lot #936019, Exp. 8/1/2024, UDI-DI 10888439914443; (9) Cat. SAN13DILC6 - Lot #22275, Exp. 5/1/2024, UDI-DI 10197106209561; (10) Cat. SAN21AO62F - Lot #901120, Exp. 8/1/2024, UDI-DI 10888439936100; (11) Cat. SAN21APJCD - Lot #922242, Exp. 8/1/2024, UDI-DI 10195594574918; (12) Cat. SAN21IP62I - Lot #917437, Exp. 6/1/2024, UDI-DI 10888439936018; (13) Cat. SAN23CMCW5 - Lot #919954, Exp. 7/1/2024, UDI-DI 10195594885915; (14) Cat. SAN29PCCCL - Lot #999073, Exp. 6/1/2027, UDI-DI 10888439917291; (15) Cat. SAN3BPDKOC - Lot #942109, Exp. 1/1/2024, UDI-DI 10888439964530; (16) Cat. SAN3BPDK12 - Lot #914221, Exp. 1/1/2024, UDI-DI 10195594863579; (17) Cat. SAN30ANTHD - Lot #16600, Exp. 7/1/2025, UDI-DI 10888439973334; (18) Cat. SAN30PPVGA - Lot #922151, Exp. 5/1/2025, UDI-DI 10195594119409; (19) Cat. SAN32IPJWA - Lot #986373, Exp. 4/1/2024, UDI-DI 10888439903881; (20) Cat. SAN33HCSFI - Lot #918244, Exp. 10/1/2024, UDI-DI 10195594302375; (21) Cat. SAN33PMDWI - Lot #973944, Exp. 9/1/2027, UDI-DI 10888439900880; (22) Cat. SAN53OPVMG - Lot #916151, Exp. 7/1/2024, UDI-DI 10195594764401; (23) Cat. SAN55PMMMK - Lot #940130, Exp. 4/1/2024, UDI-DI 10195594395247; (24) Cat. SAN55PMMM9 - Lot #920265, Exp. 9/1/2024, UDI-DI 10195594892173; (25) Cat. SAN57PM80G - Lot #918511, Exp. 4/1/2025, UDI-DI 10195594714451; (26) Cat. SAN69ENKBK - Lot #940361, Exp. 8/1/2025, UDI-DI 10888439549881; (27) Cat. SCVOCVACMI - Lot #924218, Exp. 12/1/2024, UDI-DI 10195594696924; (28) Cat. SCVW1VAHFL - Lot #945247, Exp. 8/1/2025, UDI-DI 10888439912173; (29) Cat. SCV11AVDMF - Lot #17725, Exp. 6/1/2025, UDI-DI 10197106013328;s (30) Cat. SCV11AVD13 - Lot #59718, Exp. 12/1/2025, UDI-DI 10197106306543; (31) Cat. SCV11TBTJH - Lot #940443, Exp. 2/1/2024, UDI-DI 10888439899078; (32) Cat. SCV30EVTHE - Lot #38772, Exp. 1/1/2025, UDI-DI 10888439973235; (33) Cat. SCV30PMRGA - Lot #9591, Exp. 10/1/2027, UDI-DI 10887488561110; and (34) Cat. SOT30PCHSC - Lot #54914, Exp. 3/1/2024, UDI-DI 10195594626402.
Z-0085-2024Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.; Lot #967679, Exp. 9/1/2024, UDI-DI 10195594543259.
Z-0086-2024Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.; (1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130; (2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419; (3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930; (4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153; (5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209; (6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475; (7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216; (8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811; (9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707; (10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452; (11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619; (12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795; (13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418; (14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071; (15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and (16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.
Z-0087-2024Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.; (1) Cat. PGMHSUESR - Lot #54698, Exp. 2/1/2025 and Exp. 6/1/2024, UDI-DI 10195594542757; (2) Cat. PGVGLBP20 - Lot #921831, Exp. 4/1/2024, UDI-DI 10195594892210; (3) Cat. PG63CCC31 - Lot #940845, Exp. 9/1/2023, UDI-DI 10197106032978; (4) Cat. PG63CCC34 - Lot #46817, Exp. 2/1/2024, UDI-DI 10197106279342; (5) Cat. SBAOCRBENF - Lot #985693, Exp. 7/1/2024, UDI-DI 10195594735999; (6) Cat. SBAOCRBEN8 - Lot #920306, Exp. 6/1/2024, UDI-DI 10195594882334; (7) Cat. SBA30MJCHH - Lot #937398, Exp. 4/1/2025, UDI-DI 10195594759766; (8) Cat. SBA41ALFME - Lot #981380, Exp. 12/1/2024, UDI-DI 10887488946573; (9) Cat. SBA44ACWBF - Lot #986205, Exp. 10/1/2024, UDI-DI 10888439902877; (10) Cat. SBA54LADNA - Lot #998437, Exp. 3/1/2026, UDI-DI 10888439912135; (11) Cat. SBA54LADN3 - Lot #921655, Exp. 2/1/2024, UDI-DI 10195594891275; (12) Cat. SCV30THLHA - Lot #919439, Exp. 1/1/2024, UDI-DI 10195594133559; (13) Cat. SMA57PR00B - Lot #922735, Exp. 3/1/2025, UDI-DI 10195594514259; (14) Cat. SNE69LPKVB - Lot #953055, Exp. 7/1/2024, UDI-DI 10195594578916; (15) Cat. SOP26KPMHB - Lot #17915, Exp. 9/1/2024, Exp. 8/1/2024, and Exp. 1/1/2025, UDI-DI 10888439903133; (16) Cat. SOT30PELCA - Lot #919471, UDI-DI 10195594513665; and (17) Cat. ORC511687B - Lot #18365, UDI-DI 10887488892696.
Z-0088-2024Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.; (1) Cat. SANV1PIFSB - Lot #67711, Exp. 3/1/2026, UDI-DI 10195594532048; and (2) Cat. SAN12BHGT1 - Lot #13526, Exp. 3/1/2024, UDI-DI 10197106202715.
Z-0089-2024Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile; (6) Presource PBDS Cat. PN40CD806, Kit, Pedi C D, RWJ, Sterile; (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile; (8) Presource PBDS Cat. PN73APVD7, Kit, Neuro Spine Module, Sterile; (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile; (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile; (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile; (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile; (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile; (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile; (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile; (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile; (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile; (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile; (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile; (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile; (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile; (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile; (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile; (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile; (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile; (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile; (27) Presource Complex Spine Pack, Cat. SNE12NS388, Sterile; (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile; (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile; (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile; (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile; (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile; (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile; (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile; (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile; (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile; (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile; (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile; (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile; (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile; (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile; (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile; (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile; (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile; (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile; (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.; (1) Cat. PNVMNIB21 - Lot #920364, Exp. 6/1/2024, UDI-DI 10195594891879; (2) Cat. PN08LAG13 - Lot #920368, Exp. 6/1/2024, UDI-DI 10195594886516; (3) Cat. PN08LAG17 - Lot #987136, Exp. 11/1/2024, UDI-DI 10197106132944; (4) Cat. PN11SFS40 - Lot #917897, Exp. 6/1/2024, UDI-DI 10195594875060; (5) Cat. PN33DBOU3 - Lot #918902, Exp. 8/1/2023, UDI-DI 10195594878627; (6) Cat. PN40CD806 - Lot #17765, Exp. 5/1/2024, UDI-DI 10197106202968; (7) Cat. PN73APVDE - Lot #936774, Exp. 9/1/2023, UDI-DI 10195594742065; (8) Cat. PN73APVD7 - Lot #931972, Exp. 9/1/2023, UDI-DI 10197106016787; (9) Cat. POHFSPMHC - Lot #929330, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903096; (10) Cat. SAN73PPTAC - Lot #964384, Exp. 6/1/2025, UDI-DI 10888439008166; (11) Cat. SNECGLPCOB - Lot #917630, Exp. 6/1/2024, UDI-DI 10195594560942; (12) Cat. SNECGNSEBF - Lot #940134, Exp. 8/1/2024, UDI-DI 10197106002537; (13) Cat. SNECGNSEB4 - Lot #990736, Exp. 11/1/2024, UDI-DI 10197106143315; (14) Cat. SNECGSPAUH - Lot #923838, Exp. 4/1/2024, UDI-DI 10195594271480; (15) Cat. SNECGSPSGG - Lot #17548, Exp. 11/1/2024 and Exp. 5/1/2024, UDI-DI 10197106131572; (16) Cat. SNEDKCSWDB - Lot #977629, Exp. 10/1/2024, UDI-DI 10197106029800; (17) Cat. SNEDKLLFLF - Lot #917621, Exp. 5/1/2024 and Exp. 11/1/2024, UDI-DI 10195594948528; (18) Cat. SNEHDNSRVJ - Lot #18167, Exp. 5/1/2024, UDI-DI 10888439902938; (19) Cat. SNEOCLPLSC - Lot #16886, Exp. 5/1/2025, UDI-DI 10195594963200; (20) Cat. SNEOCNPNBC - Lot #922662, Exp. 1/1/2024, UDI-DI 10887488974897; (21) Cat. SNE11LMENX - Lot #918521, Exp. 6/1/2024, UDI-DI 10195594736026; (22) Cat. SNE11SPDML - Lot #923218, Exp. 9/1/2023, UDI-DI 10195594433482; (23) Cat. SNE12ACGTY - Lot #16589, Exp. 6/1/2024, UDI-DI 10888439665093; (24) Cat. SNE12LM33J - Lot #923782, Exp. 4/1/2024, UDI-DI 10888439665116; (25) Cat. SNE12LM348 - Lot #992523, Exp. 7/1/2024, UDI-DI 10197106150399; (26) Cat. SNE12LM349 - Lot #997471, Exp. 12/1/2024, UDI-DI 10197106162149; (27) Cat. SNE12NS388 - Lot #987470, Exp. 12/1/2024, UDI-DI 10197106134146; (28) Cat. SNE12SPHMS - Lot #923360, Exp. 7/1/2024, UDI-DI 10195594660895; (29) Cat. SNE23SPGTH - Lot #999249, Exp. 1/1/2025, UDI-DI 10197106078150; (30) Cat. SNE33NROUE - Lot #919347, Exp. 12/1/2024, UDI-DI 10195594792558; (31) Cat. SNE33SPO11 - Lot #941910, Exp. 9/1/2024, UDI-DI 10197106034149; (32) Cat. SNE35NABLD - Lot #922223, Exp. 6/1/2025, UDI-DI 10888439939651; (33) Cat. SNE40SPPCH - Lot #48287, Exp. 12/1/2023 and Exp. 7/1/2024, UDI-DI 10195594455033; (34) Cat. SNE41NBCSE - Lot #990152, Exp. 10/1/2024, UDI-DI 10888439916355; (35) Cat. SNE41NBCS9 - Lot #919989, Exp. 7/1/2024, UDI-DI 10195594880538; (36) Cat. SNE43LNOG6 - Lot #34812, Exp. 5/1/2024, UDI-DI 10197106250495; (37) Cat. SNE51NBMRL - Lot #932527, Exp. 8/1/2024, UDI-DI 10888439575125; (38) Cat. SNE53NEFCH - Lot #24957, Exp. 5/1/2024 and Exp. 8/1/2024, UDI-DI 10195594368593; (39) Cat. SNE53SFVMF - Lot #986877, Exp. 2/1/2024, UDI-DI 10195594764562; (40) Cat. SNE57NP00A - Lot #930583, Exp. 7/1/2024, UDI-DI 10195594512552; (41) Cat. SNE57SPKPX - Lot #929434, Exp. 10/1/2024 and Exp. 7/1/2024, UDI-DI 10195594075507; (42) Cat. SNE69SPFRL - Lot #931449 Exp. 7/1/2024, UDI-DI 10195594447519; (43) Cat. SNE73NSCTJ - Lot #986478, Exp. 11/1/2024, UDI-DI 10195594678562; (44) Cat. SNE73SPKFL - Lot #950758, Exp. 8/1/2024, UDI-DI 10888439662986; (45) Cat. SNE73SPTAC - Lot #900047, Exp. 5/1/2024 and Exp. 6/1/2024, UDI-DI 10888439136975; (46) Cat. SNE81ACNMN - Lot #17214, Exp. 4/1/2025, and Lot #D221752, Exp. 5/1/2024, UDI-DI 10195594733018; and (47) Cat. SNE81ULNMO - Lot #931699, Exp. 5/1/2024, UDI-DI 10888439934113.
Z-0090-2024Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.; Lot #81461, Exp. 6/1/2024 and Exp. 9/1/2024, UDI-DI 10195594542795.
Z-0091-2024Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S; (1) Cat. PN33BPCR2 - Lot #986971, Exp. 9/1/2024, UDI-DI 10197106132319; (2) Cat. POCGANA11 - Lot #936749, Exp. 8/1/2024, UDI-DI 10197106027257; (3) Cat. PODKHAKAB - Lot #18022, Exp. 5/1/2024, UDI-DI 10888439441819; (4) Cat. POMHKAESV - Lot #967651, Exp. 12/1/2023, UDI-DI 10195594543341; (5) Cat. POMHLEE11 - Lot #39223, Exp. 8/1/2024, UDI-DI 10197106255087; (6) Cat. POMVTHANLE - Lot #926669, Exp. 9/1/2023, UDI-DI 10195594471781; (7) Cat. POVMPAB11 - Lot #951430, Exp. 8/1/2024, UDI-DI 50197106054701; (8) Cat. PO08LXG21 - Lot #941775, Exp. 12/1/2024, UDI-DI 10197106032404; (9) Cat. PO11HRFH6 - Lot #921333, Exp. 5/1/2024, UDI-DI 10195594894191; (10) Cat. PO11OTASS8 - Lot #920211, Exp. 2/1/2024, UDI-DI 10195594888121; (11) Cat. PO11OTSSP - Lot #57290, Exp. 4/1/2024, UDI-DI 10197106108611; (12) Cat. PO11THAS13 - Lot #966763, Exp. 8/1/2024, UDI-DI 10197106087190; (13) Cat. PO12AHSUQ - Lot #930429, Exp. 1/1/2024, UDI-DI 10195594397760; (14) Cat. PO12AHSU7 - Lot #17680, Exp. 10/1/2024, UDI-DI 10197106201329; (15) Cat. PO18AHEFG - Lot #940003, Exp. 8/1/2024, UDI-DI 10888439910193; (16) Cat. PO3LHPLM2 - Lot #905668, Exp. 6/1/2025, UDI-DI 10195594828790; (17) Cat. PO3LHPLM3 - Lot #925611, Exp. 7/1/2025, UDI-DI 10197106000298; (18) Cat. PO33AHCRA - Lot #998611, Exp. 1/1/2025, UDI-DI 10195594899264; (19) Cat. PO56MLGRA - Lot #4327, Exp. 7/1/2025, UDI-DI 10197106115008; (20) Cat. SNECGSPAHB - Lot #986454, Exp. 9/1/2024, UDI-DI 10195594020798; (21) Cat. SNECGSPAH4 - Lot #40840, Exp. 9/1/2024, UDI-DI 10197106266328; (22) Cat. SNE12OL89A - Lot #18306, Exp. 12/1/2023 and 5/1/2024, UDI-DI 10195594527723; (23) Cat. SNE33ACCRD - Lot #931311, Exp. 6/1/2024, UDI-DI 10195594895839; (24) Cat. SNE33AFC18 - Lot #941894, Exp. 8/1/2024, UDI-DI 10197106033807; (25) Cat. SNE33LMCAB - Lot #922696, Exp. 8/1/2024 and Exp. 5/1/2024, UDI-DI 10195594472559; (26) Cat. SNE73SAKSD - Lot #920769, Exp. 8/1/2024, UDI-DI 10888439615173; (27) Cat. SOPCNHAMSD - Lot #969039, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903140; (28) Cat. SOPDKAHC12 - Lot #997357, Exp. 9/1/2024, UDI-DI 10197106163337; (29) Cat. SOPHFLSHAC - Lot #998464, Exp. 4/1/2027, UDI-DI 10888439912098; (30) Cat. SOPMHHCM10 - Lot #996397, Exp. 12/1/20025, UDI-DI 10197106163634; (31) Cat. SOPOCBPLSD - Lot #893040, Exp. 4/1/2024, UDI-DI 10888439909210; (32) Cat. SOPW1OSHFM - Lot #931594, Exp. 7/1/2024, UDI-DI 10888439936759; (33) Cat. SOP11PER12 - Lot #920426, Exp. 8/1/2023, UDI-DI 10195594880781; (34) Cat. SOP12HAGTC - Lot #986429, Exp. 1/1/2024, UDI-DI 10195594961923; (35) Cat. SOP12HAUVE - Lot #64393, Exp. 11/1/2024, UDI-DI 10197106300657; (36) Cat. SOP12MJHM6 - Lot #922502, Exp. 12/1/2023, UDI-DI 10195594892081; (37) Cat. SOP22PSMRE - Lot #928986, Exp. 6/1/2024, UDI-DI 10888439917376; (38) Cat. SOP3LLESGK - Lot #959551, Exp. 4/1/2025 and Exp. 5/1/2025, UDI-DI 10195594495930; (39) Cat. SOP30ACSCG - Lot #929766, Exp. 3/1/2027, UDI-DI 10195594759780; (40) Cat. SOP30AKJTF - Lot #16244, Exp. 11/1/2027, UDI-DI 10197106080160; (41) Cat. SOP30FRUHE - Lot #986684, Exp. 12/1/2024, UDI-DI 10195594614263; (42) Cat. SOP30HALHB - Lot #924124, Exp. 12/1/2025, UDI-DI 10195594737351; (43) Cat. SOP30HPWME - Lot #991876, Exp. 6/1/2024, UDI-DI 10888439936414; (44) Cat. SOP30HSCHE - Lot #12487, Exp. 12/1/2024, UDI-DI 10888439853025; (45) Cat. SOP30OSVI8 - Lot #921913, Exp. 6/1/2027, UDI-DI 10195594891343; (46) Cat. SOP30UPOHD - Lot #929776, Exp. 10/1/2026, UDI-DI 10195594469139; (47) Cat. SOP32AHGMH - Lot #71002, Exp. 1/1/2027, UDI-DI 10197106088661; (48) Cat. SOP33ANOOI - Lot #998668, Exp. 4/1/2024, UDI-DI 10197106026588; (49) Cat. SOP33OROUJ - Lot #930189, Exp. 6/1/2024 and Exp. 5/1/2024, UDI-DI 10195594700683; (50) Cat. SOP33OROU5 - Lot #918471, Exp. 2/1/2024, UDI-DI 10195594876340; (51) Cat. SOP35AHAMG - Lot #923516, Exp. 4/1/2024, UDI-DI 10195594571696, (52) Cat. SOP41HISP6 - Lot #916958, Exp. 2/1/2024, UDI-DI 10195594873691; (53) Cat. SOP44STHPC - Lot #12393, Exp. 12/1/2024, UDI-DI 10888439912180; (54) Cat. SOP5BAHHEE - Lot #53599, Exp. 12/1/2024, UDI-DI 10195594532246; (55) Cat. SOP5BHSEHD - Lot #986063, Exp. 10/1/2024, UDI-DI 10888439654790; (56) Cat. SOP5CCJOUH - Lot #920091, Exp. 7/1/2024, UDI-DI 10195594663902; (57) Cat. SOP51BAKOF - Lot #966211, Exp. 10/1/2024, UDI-DI 10887488579931; (58) Cat. SOP51BAKO9 - Lot #927573, Exp. 6/1/2024, UDI-DI 10197106005507; (59) Cat. SOP53APKP4 - Lot #929995, Exp. 2/1/2024, UDI-DI 10197106012741; (60) Cat. SOP56HAMT8 - Lot #920050, Exp. 10/1/2023, UDI-DI 10195594882600; (61) Cat. SOP57AHSH5 - Lot #986901, Exp. 12/1/2024, UDI-DI 10197106133361; (62) Cat. SOP6VTHPOA - Lot #986320, Exp. 10/1/2024, UDI-DI 10195594408312; (63) Cat. SOP69AHKCF - Lot #915225, Exp. 3/1/2024, UDI-DI 10887488576046; (64) Cat. SOP69AHKC2 - Lot #912556, Exp. 3/1/2024, UDI-DI 10195594862879; (65) Cat. SOP69AHMRI - Lot #4205, Exp. 8/1/2024, Exp. 12/1/2024, and Exp. 6/1/2024, UDI-DI 10195594097295; (66) Cat. SOP69SHWMR - Lot #913072, Exp. 3/1/2024, UDI-DI 10195594106331; (67) Cat. SOP69TAKT3 - Lot #922930, Exp. 6/1/2024, UDI-DI 10195594892852; (68) Cat. SOP69TAKT6 - Lot #986238, Exp. 10/1/2024, UDI-DI 10197106133132; (69) Cat. SOP69TSKBA - Lot #986066, Exp. 1/1/2024, UDI-DI 10195594464431; (70) Cat. SOP73HAKPH - Lot #942491, Exp. 7/1/2024, UDI-DI 10195594446345; (71) Cat. SOP73SPDOC - Lot #970296, Exp. 2/1/2024, UDI-DI 10888439930733; and (72) Cat. SOP82AHBFK - Lot #18539, Exp. 7/1/2023 and Exp. 12/1/2023, UDI-DI 10888439974881.
Z-0092-2024Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.; Lot #23520, Exp. 2/1/2025, UDI-DI 10888439920840.
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Cardinal Health 200, LLC for specific details about the recalled packs and instructions on how to address the issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 33 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia.

Recall timeline

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

1. Firm started the recall: Aug 16, 202312. FDA classified it Class II: Oct 10, 202323. Published in FDA’s Enforcement Report: Oct 18, 202332023
  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-0090-2024 (August 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0090-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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