Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 21, 2016
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ellman International, Inc. recalled ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipo… - a moderate-severity action.
ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipo… was recalled by Ellman International, Inc. in December 21, 2016. Reason: Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not…. Check the official notice for the remedy. Verify recall #Z-0748-2017 with the FDA Devices before acting.
The recall
Ellman International, Inc. issued this moderate-severity FDA Devices recall-Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not….
- Moderate
- severity level
- Class II
- classification
- December 21, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0748-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0748-2017) was formally reported on December 21, 2016, with the manufacturer initiating the action on September 7, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ellman International, Inc. is listed as the recalling firm, operating out of Hicksville, NY. Federal records list the affected scope as 370 boxes (US - 159 boxes, OUS - 211 boxes).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
370 boxes (US - 159 boxes, OUS - 211 boxes)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0748-2017 |
| Date reported | December 21, 2016 |
| Date initiated | September 7, 2016 |
| Recalling firm | Ellman International, Inc. |
| Firm location | Hicksville, NY |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0748-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ellman International, Inc.. Units affected: 370 boxes (US - 159 boxes, OUS - 211 boxes).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0748-2017.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0748-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 21, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.