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Browse Device Recalls

24 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 24 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 24 FDA device recalls.

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DateProductReasonClassFirm
Jun 7, 2019 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RET... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVEST... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products ... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Produ... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE6... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 P... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REP... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, R... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, R... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBT... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, ... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB,... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbe... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers ... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, EC... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFV... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Produ... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC
Jun 7, 2019 Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401... The protective material used in the manufacture of the products could potentially provide inadequ... Class II Burlington Medical, LLC

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.