Bovie Medical Corporation: 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.

Agency Publication Date: August 25, 2016

Affected Products

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.

Lot 0316D, 0416L, and 0516B.

Lot Numbers:

0316D

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.

Lot 0316D and 0516B.

Lot Numbers:

0316D

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.

Lot 0316D.

Lot Numbers:

0316D

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.

Lot 0316D.

Lot Numbers:

0316D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74790

Status: Resolved

Manufacturer: Bovie Medical Corporation

Manufactured In: United States

Units Affected: 4 products (95)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot 0316D, 0416L, and 0516B.

Lot Numbers:

0316D

Lot 0316D and 0516B.

Lot Numbers:

0316D

Lot 0316D.

Lot Numbers:

0316D

Lot 0316D.

Lot Numbers:

0316D