Bovie Medical recalls J-Plasma Precise FLEX devices (BVX-500BF) made since Jan 2014 due to incomplete cable plug insertion causing potential cross-contamination if 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 FLEX surgical devices made since January 2014. The recall is because the cable plug might not seat properly, risking patient fluid backflow and cross-contamination if the generator is reused.
The J-Plasma handpiece cable plug may not fully insert into the generator receptacle. This creates an incomplete helium seal that allows patient fluids to flow back into the handpiece and generator. If the generator is reused, this could lead to cross-contamination between patients.
Surgical device users who own J-Plasma Precise FLEX devices with catalog number BVX-500BF made from January 2014 onward are most at risk. Healthcare professionals using these devices for procedures are particularly affected.
Check for the catalog number BVX-500BF on the device. The product was manufactured starting January 1, 2014. This recall applies to all units made since that date.
Verify the catalog number on the device is BVX-500BF.
Make sure the handpiece cable plug fully seats into the generator receptacle before use.
The device may not be safe if the cable plug does not fully insert into the generator receptacle, potentially causing cross-contamination if reused.
Check the catalog number on the device. If it's BVX-500BF and made since January 2014, ensure the cable plug fully seats before use to prevent potential cross-contamination.
Look for the catalog number BVX-500BF on the device. The product was manufactured starting January 1, 2014.
We’ve drafted a message you can send Bovie Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1157-2018 — Bovie Medical Bovie Medical Hello, I own a Bovie Medical that is covered by recall Z-1157-2018 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.
