Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 30, 2012 | Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray s... | During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 30, 2012 | Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Urosk... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2012 | Symbia E is a multi-purpose SPECT system used to detect or image the distribu... | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 11, 2012 | E.CAM emission computed tomography system used to detect or image the distrib... | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 24, 2012 | Siemens syngo.plaza. Radiological image processing system | Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 8, 2011 | Siemens syngo.plaza image processing system image processing radiological ... | The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" function... | Class II | Siemens Medical Solutions USA, 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.