Browse Device Recalls

150 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 150 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 150 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 10, 2022	Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K0...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob...	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man...	Class II	GE Medical Systems, LLC
Oct 28, 2022	Centricity PACS-IW with Universal Viewer version 5.0. Used to display me...	There is the potential that after installation of the IAS tool, some studies can remain hidden wi...	Class II	GE Medical Systems, LLC
Oct 28, 2022	Centricity Universal Viewer 6.0. Used to display medical images (Includi...	There is the potential that after installation of the IAS tool, some studies can remain hidden wi...	Class II	GE Medical Systems, LLC
Oct 3, 2018	SIGNA Architect system Product Usage: The Signa Architect system is a who...	A small area on the bore surface, which is normally accessible to the patient, can get warm enoug...	Class II	GE Medical Systems, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
Jun 6, 2018	Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol...	GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea...	Class II	GE Medical Systems, LLC
Mar 30, 2018	MR Surgical Suite Option Product The MR Surgical Option when integrated wi...	There is a potential safety issue with the table transfer release of the MR Surgical Suite System...	Class II	GE Medical Systems, LLC
May 11, 2017	Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is ...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system co...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGN...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, ...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage:...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whol...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
May 11, 2017	Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 ...	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent...	Class II	GE Medical Systems, LLC
Apr 20, 2016	GE, Revolution CT. The system is intended for head, whole body, cardiac, and...	An out of tolerance torque tool was used on three joints during the manufacturing process. If the...	Class II	GE Medical Systems, LLC
Apr 15, 2016	GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop...	Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie...	Class II	GE Medical Systems, LLC
Apr 15, 2016	GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop...	Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie...	Class II	GE Medical Systems, LLC
Mar 15, 2016	GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation...	The vacuum suction tubing could be kinked within the machine resulting in suction less than the 2...	Class II	GE Medical Systems, LLC
Mar 1, 2016	SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body...	Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction...	Class II	GE Medical Systems, LLC
Feb 17, 2016	GE Healthcare, Aisys Carestation.	GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c...	Class II	GE Medical Systems, LLC
Feb 17, 2016	GE Healthcare, Aisys CS2 anesthesia..	GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c...	Class II	GE Medical Systems, LLC
Feb 10, 2016	LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSp...	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	LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The Ligh...	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 ST, , 2339985 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
Feb 10, 2016	LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The...	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	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.