Bovie Medical recalls J-Plasma Precise devices with specific catalog numbers and production dates due to risk of patient fluid backflow and cross-contamination if generator is reused.
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
Bovie Medical is recalling J-Plasma Precise surgical devices with catalog numbers BVX-150B, BVX-150N, BVX-330B, BVX-330N, BVX-450B, and BVX-450N. These devices could allow patient fluid to backflow into the generator, risking cross-contamination if the generator is reused.
The handpiece cable plug may not fully insert into the generator receptacle, creating an incomplete helium seal. This can allow patient fluids to flow back into the handpiece and generator, potentially causing cross-contamination if the generator is reused.
Surgical device users who own the recalled J-Plasma Precise models with catalog numbers listed above. Patients and healthcare providers using these devices during procedures are at risk of cross-contamination.
Check for catalog numbers BVX-150B, BVX-150N, BVX-330B, BVX-330N, BVX-450B, or BVX-450N. The devices were manufactured starting January 1, 2014.
Identify the catalog number on your J-Plasma Precise device to confirm if it is in the recall list.
Reach out to Bovie Medical Corporation for guidance on next steps if your device is affected.
The risk is patient fluid backflow into the handpiece and generator, which could lead to cross-contamination if the generator is reused.
Check the catalog number on your device; it must be one of BVX-150B, BVX-150N, BVX-330B, BVX-330N, BVX-450B, or BVX-450N, and it was manufactured from January 1, 2014, onward.
The recall does not require immediate discontinuation; however, affected devices should be checked for the specific catalog numbers and production dates.
We’ve drafted a message you can send Bovie Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1154-2018 — Bovie Medical Bovie Medical Hello, I own a Bovie Medical that is covered by recall Z-1154-2018 from Bovie Medical. 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.