BVX-450NR Bovie Precise 360 Handpiece 45cm — Class II medical device recall Z-2649-2016
Terminated recall by Bovie Medical Corporation, reported 2016-08-31, distributed nationwide. The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive
| Recall number | Z-2649-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bovie Medical Corporation, Clearwater, FL, United States |
| Recall initiated | 2016-07-18 |
| Classified | 2016-08-24 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI |
| Quantity | 95 |
| Lot numbers | 0316D |
Product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Reason for recall
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
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-2649-2016. 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.