ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable — Class II medical device recall Z-0748-2017
Terminated recall by Ellman International, Inc., reported 2016-12-21, distributed in CA, FL, MA, MD, MI, MN, MS, OH…. Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not m
| Recall number | Z-0748-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ellman International, Inc., Hicksville, NY, United States |
| Recall initiated | 2016-09-07 |
| Classified | 2016-12-13 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2018-06-18 |
| Distributed | CA, FL, MA, MD, MI, MN, MS, OH, PA, TX, VA, WV |
| Countries outside the US | AU, BD, ES, GR, IT, JP, LB, SG |
| Reason classes | labeling |
| Lot numbers | 45572 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0748-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.