# FDA recall Z-2060-2020

> **Bovie Medical Corporation** · Class II · device recall initiated 2020-04-20.

## Product

Renuvion/ J-Plasma Precise Open Handpiece.  Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.

## Reason for recall

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

## Distribution

Worldwide distribution - US nationwide including in the states of Puerto Rico, and the countries of CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria, Poland, Germany, Slovakia, Spain, Cyprus, Switzerland, Turkey, UK, Italy, Bulgaria, Greece, Norway, Ireland, Hungary, and Croatia.

## Key facts

- **Recall number:** Z-2060-2020
- **Recalling firm:** Bovie Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-20
- **Report date:** 2020-05-27
- **Termination date:** 2022-09-13

- **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-2060-2020

## Citation

> AI Analytics. FDA recall Z-2060-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2060-2020. Source: US FDA. Licensed CC0.

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