Browse Device Recalls

983 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 983 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 983 FDA device recalls.

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DateProductReasonClassFirm
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/comp... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Oct 24, 2024 GE Proteus XR/A radiographic system Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have no... Class II GE Healthcare (China) Co., Ltd.
Oct 3, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... Class II GE Healthcare
Sep 3, 2024 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Sep 3, 2024 GE Heathcare Giraffe OmniBed; neo natal incubator GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Aug 29, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... Class II GE Healthcare
Aug 21, 2024 McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2... A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Horizon Cardiology Hemo. Version 12.2. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 9, 2024 GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant war... GE HealthCare has become aware that complete electrical safety testing was not conducted during m... Class II Wipro GE Healthcare Private Ltd.
Aug 9, 2024 GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1... GE HealthCare has become aware that complete electrical safety testing was not conducted during m... Class II Wipro GE Healthcare Private Ltd.
Aug 8, 2024 ViewPoint; system, imaging processing, radiological The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... Class II GE Healthcare GmbH
Aug 8, 2024 ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591... The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... Class II GE Healthcare GmbH
Aug 5, 2024 GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging proces... GE HealthCare has become aware of an issue where image storage is not possible when Centricity PA... Class II GE Healthcare
Jul 23, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not sho... Class II GE Healthcare
Jul 12, 2024 GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: ... The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for ... Class II GE Healthcare (China) Co., Ltd.
Jun 14, 2024 Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... 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 Discovery MR750w 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 Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... 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 Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... 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 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... 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 MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... 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 Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... 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 Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... 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 Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... 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 MR950, with affected software versions: 7T23.0; Nuclear Magnetic 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 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 2, 2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) ... GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... Class II GE Vingmed Ultrasound As

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.