FDA Device recall Z-2060-2020
Renuvion/ J-Plasma Precise Open Handpiece
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Renuvion/ J-Plasma Precise Open Handpiece by Bovie Medical, citing unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2060-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-20 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bovie Medical |
| Distribution | US |
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
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Identifiers
| code_info | The following Catalog numbers which were distributed from 06/01/2016 through present: BVX-044-BPS, BVX-044-BPP, BVX-15…The following Catalog numbers which were distributed from 06/01/2016 through present: BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, APYX-150-BPS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2060-2020%22
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