# FDA recall Z-0198-2019

> **Bovie Medical Corporation** · Class II · device recall initiated 2018-06-18.

## Product

J-Plasma Precise 360, single use, disposable.     The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

## Reason for recall

There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

## Distribution

Worldwide Distribution: US (nationwide) to states of::  CA, CO, FL, ID, IL, MD, MO, NJ, NY, OH, OR, PA,, TX.; and countries of: Austria, Bahrain, Belgium, Bulgaria, Cyprus, Finland, Great Britain, Hungary, Ireland, Israel, Italy, Qatar, Scandinavia, Slovakia, Switzerland, Turkey, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0198-2019
- **Recalling firm:** Bovie Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-18
- **Report date:** 2018-10-31
- **Termination date:** 2019-04-08

- **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-0198-2019

## Citation

> AI Analytics. FDA recall Z-0198-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0198-2019. Source: US FDA. Licensed CC0.

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