The FDA announced on Feb. 8, 2018, that Bovie Medical Corporation is recalling J-Plasma Precise 360 devices due to the risk of cross-contamination from incomplete helium seals. The agency said the hazard could allow patient fluid backflow into the generator if reused.
How to tell if you have it
- Brand: Bovie Medical
- Product: J-Plasma Precise 360(R)
- Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
- Lots manufactured since 01/01/2014
The hazard
The recall addresses incomplete insertion of the J-Plasma handpiece cable plug into the generator receptacle, which results in an incomplete helium seal. The FDA said this creates a potential for patient fluid backflow into the handpiece and generator receptacle, leading to a risk of cross-contamination if the generator is reused.
Context
GovInfoNow's records show Bovie Medical Corporation has issued three other recalls since June 18, 2018, including a Feb. 1, 2021 recall for disposable bipolar ablator packaging risks and an April 20, 2020 recall for handpiece shaft fracture risks. Other recent recalls of similar products include the Stryker BW Webster Duo-Decapolar Catheter recall (April 10, 2026) for incomplete sterile seals, the Medtronic DLP Retrograde Cannula recall (April 21, 2026) for sterile barrier breach risk, and the B Braun Medical IV Sets recall (Oct. 29, 2025) for backflow risk in gravity IV systems.