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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Feb 1, 2021 HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutt... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for c... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Apr 20, 2020 Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, B... Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... Class II Bovie Medical Corporation
Apr 20, 2020 Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-... Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... Class II Bovie Medical Corporation
Jun 18, 2018 J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise ... There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece sepa... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BV... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Jul 18, 2016 BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for t... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the ... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for th... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for t... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical 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.