EndoWrist One Vessel Sealer — Class II medical device recall Z-1142-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-03-04, distributed nationwide. Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit inte
| Recall number | Z-1142-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-02-11 |
| Classified | 2015-02-24 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, CN, DE, DK, EC, ES, FI, FR, GB, GR, IT, KR, NL, NO, SA, SE, TR |
| Quantity | 3,282 |
| Lot numbers | S10140730, S10140805, S10140814, S10140824, S10140827, S10140904, S10140912, S10140916, S10140923, S10141001, S10141007, S10141009, S10141015, S10141020, S10141028, S10141103, S10141111, S10141118, S10141125 |
Product
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Reason for recall
Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
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-1142-2015. 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.