Browse Device Recalls

157 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 157 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 157 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2015 GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 7, 2015 GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us... Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ... Class II GE Medical Systems, LLC
Dec 7, 2015 GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ... Class II GE Medical Systems, LLC
Nov 13, 2015 GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system... GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... Class II GE Medical Systems, LLC
Nov 13, 2015 GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste... GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... Class II GE Medical Systems, LLC
Oct 23, 2015 GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte... GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo... Class II GE Medical Systems, LLC
Sep 23, 2015 MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UP... GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Op... Class II GE Medical Systems, LLC

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.