FDA (Devices) recall action 79398
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Bovie Medical is recalling 5,416 J-Plasma handpieces worldwide because an incomplete cable seal could allow patient fluid backflow, creating a cross-contamination risk.
Bovie Medical is recalling 1,005 J-Plasma Precise OPEN units worldwide because a cable plug defect may cause an incomplete helium seal, risking cross-contamination.
Bovie Medical is recalling 12 units of the J-Plasma Precise FLEX due to a potential seal failure that could allow patient fluid backflow and cross-contamination.
Bovie Medical is recalling J-Plasma Precise 360 devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.
Bovie Medical is recalling J-Plasma Precise devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.