CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
Renuvion/ J-Plasma Precise Open Handpiece recalled by Bovie Medical
Bovie Medical is recalling Renuvion/ J-Plasma Precise Open Handpiece, distributed nationwide in the US. The recall was initiated on 20 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2060-2020
- FDA event ID
- 85597
- Recalling firm
- Bovie Medical, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2020
- FDA classified
- 20 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 20 Apr 2020 | Recall initiated by company | |
| 20 May 2020 | Classified by FDA | +30 days |
| 27 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaColoradoIllinoisMassachusettsPennsylvaniaPuerto Rico
Questions about this recall
Is Renuvion/ J-Plasma Precise Open Handpiece recalled?
Yes. Bovie Medical recalled Renuvion/ J-Plasma Precise Open Handpiece on 20 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2060-2020.
Why was it recalled?
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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