# FDA recall Z-1156-2018

> **Bovie Medical Corporation** · Class II · device recall initiated 2018-02-08.

## Product

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

## Reason for recall

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.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-1156-2018
- **Recalling firm:** Bovie Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-08
- **Report date:** 2018-03-28
- **Termination date:** 2020-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clearwater, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2018

## Citation

> AI Analytics. FDA recall Z-1156-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1156-2018. Source: US FDA. Licensed CC0.

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