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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
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.
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.

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.