Use caution Medical device recall · FDA · Published April 20, 2020

Bovie Renuvion Handpiece Recall: Risk of Fragmentation During Surgery

Bovie Medical recalls Renuvion handpieces with specific catalog numbers due to potential shaft fractures during surgery. Affected models were sold from June 2016 onward. Contact for return instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2060-2020Medical device Bovie Medical ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmBovie Medical Corporation5115 Ulmerton Rd · Clearwater, FL 33760-4004

✎ GovInfoNow plain-language explainer

Bovie Medical is recalling certain Renuvion handpieces that could fragment during surgical use, potentially causing injury. This recall affects handpieces sold from June 2016 with specific catalog numbers. Read more at govinfonow.com/recall/65355-bovie-renuvion-handpiece-recall-risk-of-fragmentation-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/65355-bovie-renuvion-handpiece-recall-risk-of-fragmentation-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2060-2020

Cite this page

“Bovie Renuvion Handpiece Recall: Risk of Fragmentation During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65355-bovie-renuvion-handpiece-recall-risk-of-fragmentation-during-surgery. Based on FDA recall #Z-2060-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2060-2020%22&limit=1).

The FDA announced on April 20, 2020, that Bovie Medical Corporation recalled Renuvion/J-Plasma Precise Open Handpieces due to unexpected stress fractures that may cause fragmentation during clinical use. Owners should contact the company for a replacement handpiece.

How to tell if you have it

Brand: Bovie Medical
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
Distribution: Worldwide distribution including US nationwide and countries such as CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria, Poland, Germany, Slovakia, Spain, Cyprus, Switzerland, Turkey, UK, Italy, Bulgaria, Greece, Norway, Ireland, Hungary, and Croatia
Units affected: 13,948

The hazard

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

Context

GovInfoNow's records show Bovie Medical Corporation has issued three other recalls since February 8, 2018. Other recent recalls of similar products include Olympus Single Use Biopsy Valve Recall (January 29, 2026), Merit Medical Custom Procedure Kit Recall (December 4, 2025), and Merit Medical Allwell Angioplasty Pack Recall (December 4, 2025).

How to tell if you have this one

Check for catalog numbers: BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, or APYX-150-BPS. These models were sold from June 1, 2016, through present.

Brand
Bovie Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US nationwide including in the states of Puerto Rico, and the countries of CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria, Poland, Germany, Slovakia, Spain, Cyprus, Switzerland, Turkey, UK, Italy, Bulgaria, Greece, Norway, Ireland, Hungary, and Croatia.

Recall number	Product, codes & lots	Quantity
Z-2060-2020	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.; 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	13,948
Z-2061-2020	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 and laparoscopic surgical procedures.; The following Catalog numbers which were distributed from 06/01/2016 through present: BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, APYX-330BPS	38,738

Based on the official FDA remedy

What to do — step by step

Check Catalog Numbers
Identify your handpiece using the catalog numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US nationwide including in the states of Puerto Rico, and the countries of CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Apr 20, 2020Firm started the recall
May 20, 2020FDA classified it Class II
May 27, 2020Published in FDA’s Enforcement Report
Sep 13, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65355-bovie-renuvion-handpiece-recall-risk-of-fragmentation-during-surgery">Bovie Renuvion Handpiece Recall: Risk of Fragmentation During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2060-2020 (April 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2060-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.