Z-1154-2018Class II

J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

Name: Z-1154-2018 J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Creator: Bovie Medical Corporation
Published: 2018-02-08
License: https://open.fda.gov/license/

Apyx Medical Corporation / initiated 2018-02-08 / Terminated / root cause: manufacturing process

FDA source

Bovie Medical Corporation began a recall of J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N on 2018-02-08. FDA classified it as Class II and gives the reason as "Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid...". 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-1154-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Posted: 2018-03-21
Terminated: 2020-09-17
Recalling firm: Apyx Medical Corporation
Product: J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated their recall on 02/08/2108 by email to distributors, and letter to the remaining consignees. Distributors were directed as follows: "We ask that you immediately: 1. Quarantine your inventory of the J-Plasma Handpieces o Provide us with a list of catalog numbers and quatities that you have on your possession using the attached Inventory List template. o Email the information to me at [email protected] Note: as soon as we receive the information from you we will ship the box labels and insert stuffer notices for the stock that you have on your possession. o After receiving these labels, please follow the attached instructions on how to add each of the insert stuffer notice and the outer box label to each of the boxes that you have on your possession. o Document the number of labels/stuffers added to each of the products on the Inventory List provided, sign and date to confirm this was performed. o Return the signed document to me via email at [email protected]. 2. Inform your customers about the correction: o Identify and contact your customers that have received the product affected by this correction. o Provide them with a copy of the Urgent Medical Device Correction Template attached to this letter. o Track and document the customer responses to ensure 100% effectiveness. o Provide us a summary of the effectiveness of this correction (number of customers impacted and number of responses received)." The remaining consignees (users of the device) were instructed as follows: "ACTIONS: At the end of each procedure, inspect the handpiece cable plug and generator receptacle for the presence of fluids. If fluids are present, immediately discontinue use of the generator. In addition to following the J-Plasma handpiece Instructions for Use, immediately begin to follow the supplemental instructions provided below to ensure that the J-Plasma handpiece cable plug is properly and co
Quantity in commerce: 6906 units
Distribution: worldwide
Product codes and lots: All lots manufactured since 01/01/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1154-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1153-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21
Z-1154-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21
Z-1155-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21
Z-1156-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21
Z-1157-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21

Product code GEI

K170188Class IIBovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorBovie Medical Corporation / cleared 2017-03-08

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)