FDA Medical Device Recalls (openFDA)
Bovie Medical Corporation: 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.
- Recall number
- Z-0198-2019
- Recalling firm
- Bovie Medical Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-06-18
- Posted
- not on file
- Terminated
- 2019-04-08
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Bovie Medical, notified customers regarding the recall on or about 06/18/2018 via a letter entitled "URGENT: MEDICAL DEVICE RECALL". The letter alerted customers to discontinue to use the device with the affected catalog and lot numbers, to return the impacted handpieces to Bovie Medical, to consider using a device which did not contain the defective component, and how to receive a replacement device. Bovie Medical indicated the resolution to this issue will be a manufacturing and/or design change to the affected handpieces. The letter also stated to complete and return the response form included with the letter within ten(10) days by email to corrections@boviemed.com or by fax to the Regulatory Affairs Department at (727) 388-4697. Questions and comments can be directed to corrections@boviemed.com or call toll free 1-800-537-2790, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
- Quantity
- 1,176 total units
- Distribution
- 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.
- Lot, serial or model codes
- Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.
- 510(k) numbers
- ["K152570"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3007593903
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28