Bovie Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-0198-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

Product Classification:

Class II

Date Initiated: June 18, 2018

Date Posted: October 31, 2018

Recall Number: Z-0198-2019

Event ID: 80544

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1,176 total units

Code Information:

Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.

Distribution Pattern:

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, Scandinavia, Slovakia, Switzerland, Turkey, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated