CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report
ellman A Cynosure Company Minor Surgery Bipolar Cable recalled
Ellman International is recalling ellman A Cynosure Company Minor Surgery Bipolar Cable, Contents: Five Disposable Bipolar, distributed in 12 states. The recall was initiated on 7 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0748-2017
- FDA event ID
- 75351
- Recalling firm
- Ellman International, Hicksville, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2016
- FDA classified
- 13 Dec 2016
- Reported
- 21 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 7 Sep 2016 | Recall initiated by company | |
| 13 Dec 2016 | Classified by FDA | +97 days |
| 21 Dec 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
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.
CaliforniaFloridaMassachusettsMarylandMichiganMinnesotaMississippiOhioPennsylvaniaTexasVirginiaWest Virginia
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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