Browse Device Recalls
352 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 352 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 352 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 25, 2012 | Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... | Class I | CareFusion 303, Inc. |
| Nov 20, 2009 | Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 20... | The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to i... | Class II | CareFusion Corporation |
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.