Browse Device Recalls

168 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 168 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 168 FDA device recalls.

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DateProductReasonClassFirm
Feb 10, 2016 LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner Syste... GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... Class II GE Medical Systems, LLC
Feb 10, 2016 Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... Class II GE Medical Systems, LLC
Dec 23, 2015 GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System ... Potential safety latch mechanism failure. The safety latch, within the column that supports the ... Class II GE Medical Systems, LLC
Dec 23, 2015 GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Des... Potential safety latch mechanism failure. The safety latch, within the column that supports the ... Class II GE Medical Systems, LLC
Dec 23, 2015 GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System ... Potential safety latch mechanism failure. The safety latch, within the column that supports the ... Class II GE Medical Systems, LLC
Dec 18, 2015 Mavig Monitor Suspension System, Model GD60, contained in the following Fluor... GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm wi... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avanc... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. ... The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... Class II GE Medical Systems, LLC
Dec 15, 2015 GE Healthcare, Aestiva 7900, 1006-9305-000. 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 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.