Browse Device Recalls
607 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 607 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 607 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 24, 2013 | 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCla... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Sep 28, 2012 | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #)... | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid A... | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rota... | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
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.