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Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

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DateProductReasonClassFirm
Nov 14, 2025 GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
Nov 14, 2025 GE Healthcare Carestation anesthesia system, product number and REF numbers: ... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
Nov 14, 2025 GE Healthcare Carestation anesthesia system, product number and REF numbers: ... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
May 16, 2025 GE Healthcare Versana Ultrasound Systems, sold under the following names and ... GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... Class II GE Medical Systems China Co., Ltd.
May 16, 2025 GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, dia... GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... Class II GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Sep 8, 2023 F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) There is a potential interruption of data communication between E-modules inserted in the F2-01 F... Class II GE Medical Systems China Co., Ltd.
Jul 24, 2018 GE 9100c NXT anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux... Class II GE Medical Systems China Co., Ltd.
Jul 24, 2018 GE Carestation 30 anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux... Class II GE Medical Systems China Co., Ltd.
Jul 24, 2018 GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux... Class II GE Medical Systems China Co., Ltd.
Oct 11, 2017 Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assem... Class II GE Medical Systems China Co., Ltd.
Oct 11, 2017 Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assem... Class II GE Medical Systems 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.