Reported May 27, 2020 · Terminated

Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS,…

Bovie Medical Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bovie Medical Corporation · 5115 Ulmerton Rd · Clearwater, FL · 33760-4004

Is this the product you have?

  • 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 Usagefor electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures
Lot codes and dates
  • The following Catalog numbers which were distributed
  • from 06/01/2016 through present
    • BVX-044-BPS
    • BVX-044-BPP
    • BVX-150-BPP
    • BVX-150-BPS
    • APYX-044-BPS
    • APYX-150-BPP
    • APYX-150-BPS
Amount recalled
13,948

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 13, 2022 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.