Bovie recalls J-Plasma Precise 360 surgical handpieces from 2016 with potential PEEK tip separation risk. Learn about affected models and safety steps.
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.
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.
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.
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.
Check for catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR. These handpieces were manufactured starting May 1, 2016.
Inspect the handpiece for any signs of PEEK tip separation before use.
Reach out to Bovie Medical Corporation for guidance on handling the device if separation occurs.
The recall states there is a potential risk of the PEEK tip separating and remaining in tissue, which could require additional procedures. However, the record does not specify if this has caused injuries.
The affected models are J-Plasma Precise 360 handpieces with catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR.
These handpieces were manufactured starting May 1, 2016.
We’ve drafted a message you can send Bovie to request your refund or repair — edit it as you like.
Subject: Recall Z-0198-2019 — Bovie Bovie Hello, I own a Bovie that is covered by recall Z-0198-2019 from Bovie. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
