Browse Device Recalls

24 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 24 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 24 FDA device recalls.

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DateProductReasonClassFirm
Jan 31, 2025 Optima MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA MR380, NMRI system, Non-US Only For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA MR355, SIGNA MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA Creator, SIGNA Explorer, NMRI systems For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 Brivo MR355, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... 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 Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... 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 Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... 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, Model Numbers: 1) 6665000-2, 2) 6670000... 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 520, Catalog number 5439126; X-ray/computed tomography s... 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 EVO, Model Number 5454001-260; 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 Maxima M, Model Number, 6670000-2; X-ray/computed t... 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 Ascend, Model number 6969000-100; X-ray/computed tom... 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 Ascend Elite, Model Number 6967000-100; X-ray/comput... 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 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.
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.

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.