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Browse Device Recalls

23 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 23 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 23 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2025 Carescape B450, Model no. 5805686 - shipped with potentially affected batteri... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monito... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (Wit... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
May 19, 2023 TruSignal Ear Sensor, REF TS-E-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Wrap Sensor, REF TS-W-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... Class II GE Healthcare Finland Oy
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... Class II GE Healthcare Finland Oy
May 25, 2018 GE Healthcare CARESCAPE Monitor B650 When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overlo... Class II GE Healthcare Finland Oy
Sep 19, 2013 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... Class I GE Healthcare, LLC

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.