Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2020 | SwiftHook sold as the following: a. Individually as SwiftHook b. Included w... | Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook com... | Class II | Handicare AB |
| Jul 28, 2016 | Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML,... | A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a lo... | Class II | Handicare AB |
| Jun 15, 2016 | EVA Floor Lifts, Model Numbers: 400, 450, 600 | After feedback from customers and internal suspicion, Handicare has become aware that abnormal us... | Class II | Handicare AB |
| Apr 15, 2014 | ReTurn 7500/7500 Aid, transfer | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw an... | Class II | Handicare USA, 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.