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Browse Device Recalls

82 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 82 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 82 FDA device recalls.

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DateProductReasonClassFirm
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPA... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
May 8, 2014 MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. Th... ConMed Corporation has received complaints regarding sparking, no output and burning at the cord ... Class II ConMed Corporation
Feb 20, 2014 Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1... ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion... Class II ConMed Corporation
Oct 23, 2013 ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf... The affected lots were exposed to a higher than acceptable level of particulate matter during man... Class II ConMed Corporation
Oct 23, 2013 ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf... The affected lots were exposed to a higher than acceptable level of particulate matter during man... Class II ConMed Corporation
May 3, 2013 PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 20... ConMed was notified by the contract manufacturer that their wire/connector supplier reported dama... Class II ConMed Corporation
Jan 28, 2013 ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, D... Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... Class II ConMed Corporation
Jan 28, 2013 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX... Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 13910... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Cata... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, ... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tip... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalo... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulati... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 13910... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tip... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Ca... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extend... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extend... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalo... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 1391... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 13911... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulati... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed 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.