Browse Device Recalls
5 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5 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 5 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 23, 2020 | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection ... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood conveni... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, 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.