The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2060-2020·Announced 2020-05-27

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

Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Open 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 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 involves a structural defect in a medical device (shaft fragmentation) which poses a significant risk of injury during surgical procedures, meeting the criteria for a Severe rating.

Plain-English summary

Bovie Medical Corporation is recalling 13,948 units of the Renuvion/J-Plasma Precise Open Handpiece. The affected catalog numbers are BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS. These devices are used for electrosurgical cutting, coagulation, and ablation of soft tissue during open 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.

The affected units were distributed worldwide, including in the United States (nationwide and Puerto Rico) and numerous international locations. The distribution period for these catalog numbers began on June 1, 2016, and continued through the present. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
Manufacturer
Bovie Medical Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
13,948

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 (6)

  • BVX-044-BPP
  • BVX-150-BPP
  • BVX-150-BPS
  • APYX-044-BPS
  • APYX-150-BPP
  • APYX-150-BPS

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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