Bovie Precise 360 Handpiece Recalled for Incomplete Tip Bonding
Bovie Medical Corporation is recalling 95 units of the BVX-330NR Bovie Precise 360 Handpiece due to potential incomplete bonding of the angled tip.
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-330NR Bovie Precise 360 Handpiece, 33cm, needle. 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 being issued because 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. The affected units are identified by Lot 0316D and 0516B.
The products were distributed worldwide, including in the United States (Maryland, Georgia, Missouri, and Florida) and Finland. Healthcare facilities and consumers should stop using the affected devices and contact Bovie Medical Corporation for further instructions.
The recalled product
- Product
- BVX-330NR Bovie Precise 360 Handpiece 33cm, 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
- 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 and 0516B.
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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