Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 17, 2011 | Automated Impella Controller (AIC) with the below product descriptions and co... | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults,... | Class I | Abiomed, Inc. |
| Dec 17, 2010 | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 8650... | Potential for early component failure. | Class II | Philips Electronics North America Corporation |
| Oct 12, 2010 | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ... | Software Version 3.1.1 does not meet navigational accuracy. | Class II | Medtronic Navigation, Inc. |
| Apr 5, 2010 | Philips Healthcare Computed Tomography X-Ray System. These devices are who... | Philips Healthcare discovered the customer was performing CTDI measurements for facility accredi... | Class II | Philips Healthcare Inc. |
| May 10, 2008 | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to p... | During two separate occasions an impactor plate on the handle broke off while being struck by a m... | Class II | SpineFrontier, 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.