Z-0198-2019 Class II Terminated
FDA device recall Z-0198-2019 was initiated by Bovie Medical Corporation on Jun 18, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 8, 2019). Affected quantity: 1,176 total units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Jun 18, 2018
- Termination Date
- Apr 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,176 total units
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.
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0198-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026