Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical device used for cutting and coagulation, which poses a significant risk of injury during procedures.
Plain-English summary
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece, Lot 0316D. This medical device is used to deliver helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
The recall was initiated because the adhesive may be inadequately applied or the assembly may be manipulated after application, resulting in an incomplete bond to the angled tip. This defect could compromise the structural integrity of the handpiece during use.
The affected units were distributed worldwide, including nationwide in the United States (specifically in Maryland, Georgia, Missouri, and Florida) and in Finland. Healthcare facilities and users should stop using the affected handpieces and contact Bovie Medical Corporation for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Bovie Medical Corporation
- Hazard
- 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.
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