Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 474 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Si... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
May 13, 2025 Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 13, 2025 Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 13, 2025 SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCT... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Numbe... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class II Cardinal Health 200, LLC
Nov 8, 2024 Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Class II Cardinal Health 200, LLC
Nov 1, 2024 Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Nov 1, 2024 Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Sep 25, 2024 Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118... Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with... Class I Cardinal Health 200, LLC
Aug 16, 2024 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jul 24, 2024 (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... Class II Cardinal Health 200, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
May 29, 2024 Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.