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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jul 18, 2013 Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 un... GE Healthcare has become aware of a potential safety issue associated with the use of GE General ... Class II Vital Signs Devices, a GE Healthcare Company
Oct 16, 2012 Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal s... Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printe... Class II Vital Signs Devices, a GE Healthcare Company
Feb 20, 2012 enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW D... The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 109... Class II Vital Signs Devices, a GE Healthcare Company

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.