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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Oct 24, 2023 CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A There is the potential that cooler-heater devices may contain bacterial contamination which could... Class II CardioQuip, LLC
Oct 24, 2023 CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A There is the potential that cooler-heater devices may contain bacterial contamination which could... Class II CardioQuip, LLC
Oct 19, 2023 CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... Class II CardioQuip, LLC
Oct 19, 2023 CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... Class II CardioQuip, LLC
Jun 24, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-1... There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the wate... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, C... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE ... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: ... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, 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.