Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Jul 27, 2010 Xoran Mini CT Scanner A description of the defect in the product or the manner in which the product fails to comply wit... Class II Xoran Technologies, Inc.
Jul 27, 2010 Xoran Minicat00202 The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... Class II Xoran Technologies, Inc.
Jul 27, 2010 Xoran MiniCAT00202 The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... Class II Xoran Technologies, Inc.
Jul 27, 2010 Xoran MiniCAT CT Scanner A description of the defect in the product or the manner in which the product fails to comply wvi... Class II Xoran Technologies, Inc.
Jul 27, 2010 Xoran Minicat00158 The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... Class II Xoran Technologies, Inc.
Dec 14, 2009 Xoran MiniCAT CT Scanner ID ENT00001 Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but ... Class II Xoran Technologies, 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.