Browse Device Recalls
302 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 302 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 302 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Feb 27, 2026 | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... | Class II | Cardinal Health 200, LLC |
| 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 |
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.