Z-2648-2016Class II

BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for...

Name: Z-2648-2016 BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for...
Creator: Bovie Medical Corporation
Published: 2016-07-18
License: https://open.fda.gov/license/

Apyx Medical Corporation / initiated 2016-07-18 / Terminated / root cause: manufacturing process

FDA source

Bovie Medical Corporation began a recall of BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue... on 2016-07-18. FDA classified it as Class II and gives the reason as "The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip". 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-2648-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-08-25
Terminated: 2016-12-14
Recalling firm: Apyx Medical Corporation
Product: BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760, Attn: Precise 360 Recall. Also, please write the authorization number RMA XXXX on the outside of the shipping container and use UPS account number 342562 and return via ground shipping and Fax or email the attached recall return response form to the email or fax indicated on the form as soon as possible and include a copy with the shipment. A completed recall return response form is required even if the customer has no product to return. If you have any questions about this recall or the product affected by the recall, call 727-803-8617.
Quantity in commerce: 95
Distribution: Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Product codes and lots: Lot 0316D.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2648-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2646-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24
Z-2647-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24
Z-2648-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24
Z-2649-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24

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)