Z-1154-2021Class II

HNM Disposable Bipolar Ablators -

Name: Z-1154-2021 HNM Disposable Bipolar Ablators -
Creator: Bovie Medical Corporation
Published: 2021-02-01
License: https://open.fda.gov/license/

Apyx Medical Corporation / initiated 2021-02-01 / Open, Classified / root cause: design

FDA source

Bovie Medical Corporation began a recall of HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical... on 2021-02-01. FDA classified it as Class II and gives the reason as "There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1154-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-01
Posted: 2021-02-26
Recalling firm: Apyx Medical Corporation
Product: HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
Quantity in commerce: 3862 units
Distribution: US Nationwide distribution in the states of CA and FL.
Product codes and lots: Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1154-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1153-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-02-26
Z-1154-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-02-26
Z-1155-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-02-26

Product code GEI

K161558Class IIBovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-AspiratingBovie Medical Corporation / cleared 2016-07-29

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)