Class II — Intuitive Surgical, Inc.
| Recalling firm | Intuitive Surgical, Inc. |
|---|---|
| Registered facility | View this company's 41 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 3282 total units, all part numbers |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| Initiated | 2015-02-11 |
| Classified | 2015-02-24 |
| Terminated | 2015-06-01 |
| Recall number | Z-1141-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intuitive Surgical, Inc. (Z-1141-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70467/
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