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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Jul 21, 2021 CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-... Device failed to function as intended and/or failed to conform to their design specifications. Class II Trophy SAS
Sep 18, 2012 CareStream Dental CS 2200 X-ray system Product Usage: The expected usage... There have been approximately 2% of the x-ray generators manufactured between February 2012 and N... Class II Trophy Sas
Sep 18, 2012 CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The ex... There have been approximately 2% of the x-ray generators manufactured between February 2012 and N... Class II Trophy Sas
Sep 18, 2012 CareStream Dental CS 2100 X-ray system Product Usage: The expected usage ... There have been approximately 2% of the x-ray generators manufactured between February 2012 and N... Class II Trophy Sas
Sep 18, 2012 CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The ex... There have been approximately 2% of the x-ray generators manufactured between February 2012 and N... Class II Trophy Sas

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.