EndoWrist One Vessel Sealer — Class II medical device recall Z-1141-2015
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-1141-2015 |
|---|---|
| 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 units |
Product
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05
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-1141-2015. 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.