The Recall Desk
HighFDA (Devices)·Z-1154-2018·Announced 2018-03-28

Bovie Medical Recalls J-Plasma Precise Devices Due to Cross-Contamination Risk

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device defect that poses a risk of cross-contamination, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Bovie Medical Corporation is issuing a correction for the J-Plasma Precise(R) medical devices, including catalog numbers BVX-150B, BVX-150N, BVX-330B, BVX-330N, BVX-450B, and BVX-450N. The recall affects 6,906 units distributed worldwide, specifically those manufactured since January 1, 2014.

The recall is being issued to address a defect where the handpiece cable plug may not insert completely into the generator receptacle. This incomplete insertion can result in an incomplete helium seal. If the seal is not complete, there is a potential for patient fluid to backflow into the handpiece and the generator receptacle.

This backflow creates a risk of cross-contamination if the generator is reused. The source text does not report any specific illnesses or injuries associated with this defect. Healthcare providers and consumers should verify their device catalog numbers and manufacturing dates against the recall information provided by Bovie Medical.

The recalled product

Product
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Affected units
6,906

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots manufactured since 01/01/2014

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →