Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable Recalled by Ellman International, Inc. Due to Mislabeling

Date: September 7, 2016
Company: Ellman International, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ellman International, Inc. directly.

Affected Products

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.

Quantity: 370 boxes (US - 159 boxes, OUS - 211 boxes)

Why Was This Recalled?

Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.

Where Was This Sold?

This product was distributed to 12 states: CA, FL, MD, MA, MI, MN, MS, OH, PA, TX, VA, WV

Affected (12 states)Not affected

About Ellman International, Inc.

Ellman International, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report