Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 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 3 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 18, 2023 | Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. | Labeling being updated to assure user is securing the siderail to a locked position to prevent po... | Class II | Linet Spol. S.r.o. |
| Nov 13, 2019 | Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1G... | A component used within the side rail mechanism may malfunction, resulting in the side rail eithe... | Class II | Linet Spol. S.r.o. |
| Jan 7, 2019 | AVE 2 Birthing Bed | LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by ... | Class II | Linet Spol. S.r.o. |
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.