Renuvion/ J-Plasma Precise Open Handpiece — Class II medical device recall Z-2060-2020
Terminated recall by Bovie Medical Corporation, reported 2020-05-27, distributed nationwide. Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
| Recall number | Z-2060-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bovie Medical Corporation, Clearwater, FL, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2022-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CH, CY, DE, DK, ES, GB, GR, HR, HU, IE, IT, JP, LT, NO, PL, SK, TR |
| Quantity | 13,948 |
| Reason classes | device malfunction |
| Model numbers | APYX-044-BPS, APYX-150-BPP, APYX-150-BPS, BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2060-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.