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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 24, 2021 Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by ... Aftermarket front bezel components were installed during service/repair, not by the original manu... Class I Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFC... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possib... Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFP... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX,... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 11, 2019 Ultrasound Transducer (M2736A), that may have been serviced with the followin... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have be... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco+ transducer with ECG/IUP capability (wired), that may have been serviced... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 External Toco Transducer (M1355A), that may have been serviced with the follo... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may ha... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco M2734A, that may have been serviced with the following: Pacific Medical ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco MP Transducer (M2734B), that may have been serviced with the following: ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced wit... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Ultrasound Transducer (M1356A), that may have been serviced with the followin... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group 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.