J-Plasma Precise 360 — Class II medical device recall Z-0198-2019
Terminated recall by Bovie Medical Corporation, reported 2018-10-31, distributed nationwide. There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from t
| Recall number | Z-0198-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bovie Medical Corporation, Clearwater, FL, United States |
| Recall initiated | 2018-06-18 |
| Classified | 2018-10-19 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2019-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BH, CH, CY, FI, GB, HU, IE, IL, IT, QA, SK, TR |
| Quantity | 1,176 units |
| Model numbers | BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR |
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.
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-0198-2019. 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.