J-Plasma — Class II medical device recall Z-1155-2018
Terminated recall by Bovie Medical Corporation, reported 2018-03-28. Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug
| Recall number | Z-1155-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bovie Medical Corporation, Clearwater, FL, United States |
| Recall initiated | 2018-02-08 |
| Classified | 2018-03-21 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2020-09-17 |
| Quantity | 5,416 units |
| Reason classes | packaging |
| Model numbers | BVX-270B, GS-018C, GS-270C |
Product
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Reason for recall
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
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-1155-2018. 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.