FDA Medical Device Recalls (openFDA)
Ellman International, Inc.: 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.
- Recall number
- Z-0748-2017
- Recalling firm
- Ellman International, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-09-07
- Posted
- not on file
- Terminated
- 2018-06-18
- Reason
- 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.
- Root cause
- Employee error
- Action
- Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to choy@cynosure.com. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.
- Quantity
- 370 boxes (US - 159 boxes, OUS - 211 boxes)
- Distribution
- Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.
- Lot, serial or model codes
- Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02
- 510(k) numbers
- ["K123366"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2428235
- Firm city
- Hicksville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28