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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
Apr 24, 2014 Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Pro... Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 1... Class II Mar Cor Purification
Jun 26, 2013 Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 302... High inlet water pressure beyond specification and the solenoid valve does not meet application w... Class II Mar Cor Purification
Jun 27, 2012 Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. There exists a potential situation with the crimp connection at the pump head assembly. The pote... Class II Mar Cor Purification

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.