Bovie Medical Recalls J-Plasma Handpieces Due to Incomplete Cable Seal
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (cross-contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Bovie Medical Corporation is issuing a correction for 5,416 J-Plasma(R) Handpieces, including catalog numbers GS-018C, GS-270C, and BVX-270B. The recall covers all lots manufactured since January 1, 2014, and the devices were distributed worldwide.
The recall is being issued to address incomplete insertion of the handpiece cable plug into the generator receptacle, which results in an incomplete helium seal. This defect creates a potential for patient fluid to backflow into the handpiece and the generator receptacle. If the generator is reused, this backflow leads to a risk of cross-contamination.
Healthcare providers should stop using the affected handpieces and contact Bovie Medical Corporation for further instructions on the correction.
The recalled product
- Product
- J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 5,416
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.
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