FDA Device recall Z-0198-2019
J-Plasma Precise 360, single use, disposable
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of J-Plasma Precise 360, single use, disposable by Bovie Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0198-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-18 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bovie Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2019%22
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