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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
Aug 22, 2016 The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom ... Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement ... Class II EKOS Corporation
Aug 9, 2016 EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter The recalling firm identified ten devices which were distributed and could potentially be non-com... Class II EKOS Corporation
Jan 21, 2016 EkoSonic Endovascular System, Catalog Number 500-56112. It consists of thr... The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug... Class II EKOS Corporation
Jun 24, 2015 The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSo... The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. Class II EKOS Corporation
Oct 2, 2013 The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low powe... The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. ... Class II EKOS Corporation
May 24, 2012 EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118;... EKOS Corporation have recently received several complaints from users where the radio-opaque mark... Class II EKOS Corporation

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.