Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 1, 2010 | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiograp... | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. | Class II | Canon Inc. |
| Jul 29, 2010 | TD-Synergy. Laboratory Information System. | Technidata has discovered that using the F8 key in the ERM session to add a combined test can res... | Class II | Technidata S.A. |
| Dec 29, 2009 | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV53... | In the vast majority of products specified, a shrinkage of the air chamber during sterilization h... | Class II | Spiegelberg Gmbh & Co. KG |
| Jun 9, 2009 | NDI P7 Position Sensor, Stereotaxic Instrument | Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras)... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Jun 4, 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk o... | Class II | Orthosoft, Inc. dba Zimmer CAS |
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.