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 |
|---|---|---|---|---|
| Mar 15, 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... | Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices a... | Class II | Claymount Assembli |
| Mar 15, 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... | Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the m... | Class II | Claymount Assembli |
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.