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 |
|---|---|---|---|---|
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300B (18-350-70); | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300BX (18-351-70). | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Oct 10, 2013 | Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 ... | Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... | Class II | Mizuho America, Inc. |
| Oct 10, 2013 | Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent ... | Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... | Class II | Mizuho America, 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.