DS Titanium Ligation Clip — Class II medical device recall Z-1290-2018
Terminated recall by Aesculap Implant Systems LLC, reported 2018-04-11. Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraind
| Recall number | Z-1290-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2018-01-22 |
| Classified | 2018-04-02 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-09-24 |
| Countries outside the US | CA |
| Quantity | 9,621 |
| Reason classes | unapproved product |
Product
DS Titanium Ligation Clip, used in laparoscopic surgery
Reason for recall
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
Machine access
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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.