EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si… — Class II medical device recall Z-0063-2015
Terminated recall by Intuitive Surgical, Inc., reported 2014-10-22, distributed nationwide. Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with
| Recall number | Z-0063-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-09-17 |
| Classified | 2014-10-10 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, IT, JP, KR, NL, NO, SE, TR |
| Quantity | 1,483 devices |
| Reason classes | labeling, software |
| Serial numbers | SH0021, SH0022, SH0025, SH0030, SH0032, SH0034, SH0039, SH0040, SH0041, SH0045, SH0048, SH0052, SH0062, SH0069, SH0073, SH0076, SH0078, SH0079, SH0080, SH0081, SH0084, SH0087, SH0098, SH0101, SH0108 and 475 more |
| Model numbers | 410322-04 |
Product
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D 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 is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
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-0063-2015. 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.