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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
May 13, 2025 Allon 2001. Part Number: 200-00263 An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exce... Class II Belmont Instrument LLC
Mar 31, 2025 Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. St... Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... Class II Belmont Instrument LLC
Mar 31, 2025 Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Steri... Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... Class II Belmont Instrument LLC
Mar 31, 2025 Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, singl... Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... Class II Belmont Instrument LLC
Mar 31, 2025 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/... Potential crack in the female connector located on the Heat Exchanger/patient line set, which wil... Class II Belmont Instrument LLC
Jan 2, 2025 Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI... Disposable set may leak during priming from a female quick connector due to a crack in the female... Class II Belmont Instrument 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.