Z-0198-2019Class II

J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the...

Name: Z-0198-2019 J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the...
Creator: Bovie Medical Corporation
Published: 2018-06-18
License: https://open.fda.gov/license/

Apyx Medical Corporation / initiated 2018-06-18 / Terminated / root cause: manufacturing process

FDA source

Bovie Medical Corporation began a recall of 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... on 2018-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0198-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-18
Posted: 2018-10-19
Terminated: 2019-04-08
Recalling firm: Apyx 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA 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 [email protected] or by fax to the Regulatory Affairs Department at (727) 388-4697. Questions and comments can be directed to [email protected] or call toll free 1-800-537-2790, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
Quantity in commerce: 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.
Product codes and lots: Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0198-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-19

Product code GEI

K152570Class IIBovie J-Plasma Precise 360 HandpieceBovie Medical Corporation / cleared 2015-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)