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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
Dec 10, 2024 Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Pa... Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized ... Class I Mercury Enterprises, Inc. dba Mercury Medical
Aug 30, 2024 Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric em... Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. Class I Mercury Enterprises, Inc. dba Mercury Medical
Oct 22, 2015 Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Te... Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit a... Class II Mercury Enterprises, Inc. dba Mercury Medical

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.