The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2647-2016·Announced 2016-08-31

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.

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 3/5 (High).

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
Category
Medical Device — Surgical Instrument
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 and 0516B.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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 →

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