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Use caution Medical device recall · FDA · Published February 8, 2018

Bovie J-Plasma Precise 360(R) recall: Risk of cross-contamination from incomplete cable

Bovie Medical recalls J-Plasma Precise 360(R) devices with specific catalog numbers and production dates due to risk of patient fluid backflow and cross-contamination if the generator is reused.

🇺🇸 FDA recall #Z-1156-2018Medical deviceBovie Medical ›
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Recalling firmBovie Medical Corporation5115 Ulmerton Rd · Clearwater, FL 33760-4004
✎ GovInfoNow plain-language explainer

Bovie Medical is recalling J-Plasma Precise 360(R) surgical devices with catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, and BVX-450NR. The recall is because the cable plug might not seal properly, which could let patient fluids flow back into the device and cause cross-contamination if the generator is reused. Read more at govinfonow.com/recall/71995-bovie-j-plasma-precise-360-r-recall-risk-of-cross.

Source Summary by GovInfoNow · govinfonow.com/recall/71995-bovie-j-plasma-precise-360-r-recall-risk-of-cross · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1156-2018

Cite this page

“Bovie J-Plasma Precise 360(R) recall: Risk of cross-contamination from incomplete cable.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/71995-bovie-j-plasma-precise-360-r-recall-risk-of-cross. Based on FDA recall #Z-1156-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1156-2018%22&limit=1).

The FDA announced on Feb. 8, 2018, that Bovie Medical Corporation is recalling J-Plasma Precise 360 devices due to the risk of cross-contamination from incomplete helium seals. The agency said the hazard could allow patient fluid backflow into the generator if reused.

How to tell if you have it

  • Brand: Bovie Medical
  • Product: J-Plasma Precise 360(R)
  • Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
  • Lots manufactured since 01/01/2014

The hazard

The recall addresses incomplete insertion of the J-Plasma handpiece cable plug into the generator receptacle, which results in an incomplete helium seal. The FDA said this creates a potential for patient fluid backflow into the handpiece and generator receptacle, leading to a risk of cross-contamination if the generator is reused.

Context

GovInfoNow's records show Bovie Medical Corporation has issued three other recalls since June 18, 2018, including a Feb. 1, 2021 recall for disposable bipolar ablator packaging risks and an April 20, 2020 recall for handpiece shaft fracture risks. Other recent recalls of similar products include the Stryker BW Webster Duo-Decapolar Catheter recall (April 10, 2026) for incomplete sterile seals, the Medtronic DLP Retrograde Cannula recall (April 21, 2026) for sterile barrier breach risk, and the B Braun Medical IV Sets recall (Oct. 29, 2025) for backflow risk in gravity IV systems.

How to tell if you have this one

Check for the catalog numbers BVX-330BR, BVX-330NR, BVX-450BR, or BVX-450NR on the device. These models were manufactured starting January 1, 2014.

  • Brand
    Bovie Medical
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    worldwide
Recall numberProduct, codes & lotsQuantity
Z-1153-2018J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS; All lots manufactured since 01/01/20141005 units
Z-1154-2018J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N; All lots manufactured since 01/01/20146906 units
Z-1155-2018J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B; All lots manufactured since 01/01/20145416 units
Z-1156-2018J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR; All lots manufactured since 01/01/2014595 units
Z-1157-2018J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF; All lots manufactured since 01/01/201412 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify the catalog number on the device to confirm if it is in the recalled list.

  2. Contact Manufacturer

    Reach out to Bovie Medical for guidance on next steps if the device is recalled.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Feb 8, 201812. FDA classified it Class II: Mar 21, 201823. Published in FDA’s Enforcement Report: Mar 28, 201834. FDA terminated the recall: Sep 17, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1156-2018 (February 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1156-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA