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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
Apr 17, 2018 Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C6... There is a potential for the cord to spark and cause a fire. Class II Gyrus Acmi, Incorporated
May 8, 2015 Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 8, 2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... Class II Gyrus Acmi, Incorporated
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated
Oct 17, 2012 PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, ST... One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated wi... Class II Gyrus Acmi, Incorporated

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.