Browse Device Recalls
2 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2 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 2 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 23, 2013 | ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring Syste... | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... | Class II | Sotera Wireless, Inc. |
| May 23, 2013 | ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The... | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... | Class II | Sotera Wireless, 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.