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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
Feb 26, 2015 CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telesco... Leaks were detected in the recalled lot which may compromise the sterility of the product. Class II Civco Medical Instruments Inc
Aug 1, 2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... A pinhole leak identified in the packaging of the recalled product potentially could compromise t... Class II Civco Medical Instruments Inc
Oct 25, 2013 Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cush... Scales adhered to the product may be misaligned from the zero reference such that one side will n... Class II Civco Medical Instruments Inc
Oct 25, 2013 Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion... Scales adhered to the product may be misaligned from the zero reference such that one side will n... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc

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.