Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1156-2018 — J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

U.S. FDA — Device Enforcement · United States · 2018-02-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1156-2018
Date of alert
2018-02-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bovie Medical Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.