Browse Device Recalls
275 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 275 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 275 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 26, 2025 | Chest Drainage Units and Accessories: Product Code Description 1. 88885... | The firm is updating the IFU to clarify the intended patient population for the identified chest ... | Class II | Cardinal Health 200, LLC |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SAL... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| 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 |
| 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 |
| 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 |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| Apr 17, 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... | Potential contamination of the product with latex adhesive residual. | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | 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.