FDA Device recall Z-2646-2016
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablat…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablat… by Bovie Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2646-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-18 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bovie Medical |
| Distribution | US |
Product
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade 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
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.
Identifiers
| code_info | Lot 0316D, 0416L, and 0516B. |
|---|
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-2646-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.