Bovie Medical Recalls
15 recalls on record · August 31, 2016 to March 10, 2021 · Medical Devices
Recalls by year
16
18
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 10, 2021Medical DevicesFDA
Bovie Medical Corporation recalls ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of so
Hazard: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
March 10, 2021Medical DevicesFDA
Bovie Medical Corporation recalls HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft
Hazard: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
March 10, 2021Medical DevicesFDA
Bovie Medical Corporation recalls Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of
Hazard: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
May 27, 2020Medical DevicesFDA
Bovie Medical Corporation recalls Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B
Hazard: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
May 27, 2020Medical DevicesFDA
Bovie Medical Corporation recalls Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044
Hazard: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
October 31, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of h
Hazard: There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.
March 28, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Hazard: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
March 28, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Hazard: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
March 28, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Hazard: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
March 28, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Hazard: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
March 28, 2018Medical DevicesFDA
Bovie Medical Corporation recalls J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Hazard: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
August 31, 2016Medical DevicesFDA
Bovie Medical Corporation recalls BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cuttin
Hazard: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
August 31, 2016Medical DevicesFDA
Bovie Medical Corporation recalls BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting,
Hazard: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
August 31, 2016Medical DevicesFDA
Bovie Medical Corporation recalls BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cuttin
Hazard: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
August 31, 2016Medical DevicesFDA
Bovie Medical Corporation recalls BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting
Hazard: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.