STAPLER — Class II medical device recall Z-2675-2016
Terminated recall by Intuitive Surgical, Inc., reported 2016-09-07, distributed nationwide. Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instrument
| Recall number | Z-2675-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2016-07-14 |
| Classified | 2016-08-26 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, DK, ES, FR, IT, JP, SE, TR, TW |
| Model numbers | 470298, IS4000 |
Product
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
Reason for recall
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
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-2675-2016. 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.