Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 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 922 FDA device recalls in WI.

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Date	Product	Reason	Class	Firm
Jun 4, 2021	SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA MR380, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance sca...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With ...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Artist, Nuclear Magnetic Resonance Imaging System	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
Jun 4, 2021	SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner des...	GE Healthcare has recently become aware of an issue on the affected products listed below where t...	Class II	GE Healthcare, LLC
May 21, 2021	CARESCAPE PDM-Masimo SpO2. Physiological data monitor.	Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power d...	Class II	GE Healthcare, LLC
Apr 19, 2021	Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic...	If a certain sequence of events occur, the pdf test report that belongs to one patient will appea...	Class II	GE Healthcare, LLC
Apr 19, 2021	GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682...	The IGS system can experience a single vertical line defect where the vertical line divides and h...	Class II	GE Healthcare, LLC
Mar 31, 2021	ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte...	Devices do not meet IEC 60601-2-27 requirements as labeled.	Class II	Welch Allyn Inc Mortara
Mar 31, 2021	ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte...	Devices do not meet IEC 60601-2-27 requirements as labeled.	Class II	Welch Allyn Inc Mortara
Mar 31, 2021	AM12M Acquisition Module accessory. Impacted software version of the AM12M i...	Devices do not meet IEC 60601-2-27 requirements as labeled.	Class II	Welch Allyn Inc Mortara
Mar 31, 2021	Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces...	Devices do not meet IEC 60601-2-27 requirements as labeled.	Class II	Welch Allyn Inc Mortara
Mar 19, 2021	Centricity Universal Viewer - Product Usage: intended to assist in the viewi...	When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workfl...	Class II	GE Healthcare, LLC
Mar 19, 2021	Revolution CT	GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimato...	Class II	GE Healthcare, LLC
Mar 18, 2021	Gentueri Viral Transport Medium (VTM), Sterile, IVD	Medium showed visual turbidity and discoloration, potentially contaminating samples transported f...	Class II	Gentueri Inc
Feb 26, 2021	CyberKnife Treatment Delivery System - Product Usage: indicated for image-gui...	The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen...	Class II	Accuray Incorporated
Feb 7, 2021	NM/CT 850 Nuclear Medicine / CT Scanners	GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause...	Class II	GE Healthcare, LLC
Feb 7, 2021	NM/CT 870 DR Nuclear Medicine / CT Scanners	GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus...	Class II	GE Healthcare, LLC
Feb 7, 2021	NM/CT 860 Nuclear Medicine / CT Scanners	GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus...	Class II	GE Healthcare, LLC
Dec 17, 2020	System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex...	GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E...	Class II	GE Healthcare, LLC
Dec 17, 2020	System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.	GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex E...	Class II	GE Healthcare, LLC
Dec 10, 2020	TomoTherapy Treatment System - Product Usage: used as an integrated system fo...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated
Dec 10, 2020	TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an i...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated
Dec 10, 2020	Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General N...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Dec 10, 2020	GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for genera...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Dec 10, 2020	GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for genera...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Dec 10, 2020	GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) ...	GE Healthcare has become aware of a potential safety issue associated with the improper installat...	Class II	GE Healthcare, LLC
Dec 10, 2020	Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Dis...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Dec 10, 2020	Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 N...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Dec 10, 2020	GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for ge...	GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ...	Class II	GE Healthcare, LLC
Nov 23, 2020	Revolution CT with Apex Edition CT System - Product Usage: intended for head,...	A potential for protocol(s) with unintended patient orientation or scan setting when using Intel...	Class II	GE Healthcare, LLC
Nov 23, 2020	Revolution CT ES - Product Usage: intended for head, whole body, cardiac and ...	A potential for protocol(s) with unintended patient orientation or scan setting when using Intell...	Class II	GE Healthcare, LLC
Nov 11, 2020	ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance...	The radio within the device can become disassociated with the wireless access point.	Class II	WELCH ALLYN, INC/MORTARA
Oct 27, 2020	MAC VU360, Electrocardiograph	Incorrect patient identification and/or patient demographic errors.	Class II	GE Healthcare, LLC
Sep 30, 2020	COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant compo...	The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval...	Class II	Merz North America, Inc.
Sep 21, 2020	Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product U...	There is a potential for a smudge artifact that could be suspect for pathology in some images due...	Class II	GE Healthcare, LLC
Sep 17, 2020	GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to p...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Flow Sensor Service Part, Catalog 2087640-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Flow Sensor Service Part, Catalog 2096513-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to pro...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	9100c NXT system - Product Usage: Device is licensed and distributed outside ...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Flow Sensor Service Part, Catalog 2089610-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 8, 2020	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet...	Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.	Class II	GE Healthcare, LLC
Sep 8, 2020	System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m...	Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.	Class II	GE Healthcare, LLC
Sep 8, 2020	System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m...	Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.	Class II	GE Healthcare, LLC
Sep 8, 2020	System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m...	Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.	Class II	GE Healthcare, 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.