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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.
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.
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private 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.