The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2061-2020·Announced 2020-05-27

Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

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 involves a risk-of-harm medical device where fragmentation could cause injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces, including catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX-330BPS, APYX-150B, APYX-270B, APYX-330B, APYX-270BPP, and APYX-330BPS. These devices are used for electrosurgical cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

The recall was initiated because unexpected stress fractures on the shaft of the handpiece may result in fragmentation during clinical use. The source text does not report any specific injuries or illnesses associated with this defect.

A total of 38,738 units were distributed worldwide, including in the United States, Puerto Rico, and numerous international countries. Healthcare facilities and users should stop using the affected handpieces and contact Bovie Medical Corporation for further instructions.

The recalled product

Product
Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
Manufacturer
Bovie Medical Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
38,738

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 (9)

  • BVX-270B
  • BVX-330B
  • BVX-270BPP
  • BVX- 330BPS
  • APYX-150B
  • APYX-270B
  • APYX-330B
  • APYX- 270BPP
  • APYX-330BPS

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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