Bovie J-Plasma Precise 360 Handpiece: Risk of PEEK Tip Separating in Tissue
Bovie recalls J-Plasma Precise 360 surgical handpieces from 2016 with potential PEEK tip separation risk. Learn about affected models and safety steps.
Use caution until it’s fixed
There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.
Contact the company
What happened, in plain English
Bovie is recalling J-Plasma Precise 360 surgical handpieces that may have a PEEK tip that separates from the handpiece and stays in tissue. This could cause complications during surgery if the tip is not properly removed. Read more at govinfonow.com/recall/70835-bovie-j-plasma-precise-360-handpiece-risk-of-peek-tip.
Source Summary by GovInfoNow · govinfonow.com/recall/70835-bovie-j-plasma-precise-360-handpiece-risk-of-peek-tip · Updated August 21, 2026 · FDA enforcement record: FDA #Z-0198-2019
Cite this page
“Bovie J-Plasma Precise 360 Handpiece: Risk of PEEK Tip Separating in Tissue.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70835-bovie-j-plasma-precise-360-handpiece-risk-of-peek-tip. Based on FDA recall #Z-0198-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2019%22&limit=1).
Why it’s dangerous
The PEEK tip can detach from the handpiece during use and remain inside tissue. This poses a risk of complications if the tip is not properly removed after surgery, potentially requiring additional procedures.
Who’s affected
Surgical teams using the J-Plasma Precise 360 handpieces for procedures like cutting or coagulating tissue. Patients undergoing surgery with this device are at risk if the PEEK tip becomes retained.
How to tell if you have this one
Check for catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR. These handpieces were manufactured starting May 1, 2016.
- Brand
Bovie- Category
Medical device
What to do — step by step
Check for Separation
Inspect the handpiece for any signs of PEEK tip separation before use.
Contact Manufacturer
Reach out to Bovie Medical Corporation for guidance on handling the device if separation occurs.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to states of:: CA, CO, FL, ID, IL, MD, MO, NJ, NY, OH, OR, PA,, TX.; and countries of: Austria, Bahrain, Belgium, Bulgaria, Cyprus, Finland, Great Britain, Hungary, Ireland, Israel, Italy, Qatar,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Idaho, Illinois, Maryland, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0198-2019 (June 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0198-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 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.