Bovie Precise 360 Handpiece Recalled for Incomplete Adhesive Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bovie Medical Corporation is recalling 95 units of the BVX-450BR Bovie Precise 360 Handpiece 45cm, blade. This medical device is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
The recall is due to a potential manufacturing defect where the adhesive may be inadequately applied or the assembly may be manipulated after application, resulting in an incomplete bond to the angled tip. The affected units are identified by Lot 0316D.
The products were distributed worldwide, including nationwide in the United States in the states of Maryland, Georgia, Missouri, and Florida, as well as in Finland. Healthcare providers and facilities should stop using the affected devices and contact Bovie Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- BVX-450BR Bovie Precise 360 Handpiece 45cm, 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.
- Manufacturer
- Bovie Medical Corporation
- Affected units
- 95
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 0316D.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Bovie Medical Corporation
See all →- ModerateBovie Velocity Disposable Bipolar Ablators Recalled for Sterile Packaging Defect
FDA (Devices) · 2021-03-10
- ModerateBovie Medical Recalls ConMed Disposable Bipolar Ablators Due to Packaging Defect
FDA (Devices) · 2021-03-10
- ModerateBovie Medical Recalls HNM Disposable Bipolar Ablators Due to Packaging Defect
FDA (Devices) · 2021-03-10
- SevereBovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk
FDA (Devices) · 2020-05-27
- HighBovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk
FDA (Devices) · 2020-05-27
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25