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 14, 2024	SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25....	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30....	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25....	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30....	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
Jun 14, 2024	SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3...	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can...	Class II	GE Medical Systems, LLC
May 31, 2024	ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external def...	G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the scr...	Class II	Zoll Medical Corporation
Apr 22, 2024	Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology...	Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resul...	Class II	GE Medical Systems Information Technologies Inc
Apr 9, 2024	GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON...	Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.	Class II	GE Medical Systems Information Technologies Inc
Feb 7, 2024	natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla ...	Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol...	Class II	Natus Neurology Inc
Feb 7, 2024	TENSIVE Conductive Adhesive Gel, REF 016-401600	Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol...	Class II	Natus Neurology Inc
Dec 29, 2023	EVair air compressor, model numbers: M1230849 and M1230847	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Dec 29, 2023	EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230...	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Dec 29, 2023	EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Nov 7, 2023	Navik 3D v2, REF NAVIK3D, 3D Mapping System	IFU update	Class III	APN Health LLC
Aug 8, 2023	Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #...	The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.	Class I	Mallinckrodt Manufacturing LLC
Aug 8, 2023	Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model...	A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could ...	Class II	GE Medical Systems Information Technologies Inc
Aug 3, 2023	Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for ...	It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide e...	Class II	Accuray Incorporated
Jul 6, 2023	SofTech Pressure-Sensing Wheelchair Cushions	Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p...	Class II	Aquila Corporation
Jul 6, 2023	APK2 Pressure-Sensing Wheelchair Cushions	Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p...	Class II	Aquila Corporation
Jun 6, 2023	GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator a...	Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo...	Class I	DATEX--OHMEDA, INC.
Jun 6, 2023	GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb...	Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo...	Class I	DATEX--OHMEDA, INC.
May 19, 2023	Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-9...	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
May 19, 2023	Beside panel FRU (Field Replacement Units) Kits	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
May 19, 2023	Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 20...	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
Nov 16, 2022	B125M Patient Monitor, REF 6160000-005-XXXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105M Patient Monitor, REF 6160000-003	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B125P Patient Monitor (with E-module slot option), REF 6160000-002	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B125M Patient Monitor, REF 6160000-004-XXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 10, 2022	Vivid i 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 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 q N ultrasound. Not marketed in the US. Used in ultrasound imagin...	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 q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obs...	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 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

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.