STAPLER 45 — Class II medical device recall Z-2348-2016
Terminated recall by Intuitive Surgical, Inc., reported 2016-08-17, distributed in PR. An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Fi
| Recall number | Z-2348-2016 |
|---|---|
| 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 | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-01-03 |
| Distributed | PR |
| Countries outside the US | AT, AU, BE, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IT, JP, KR, NL, NO, PT, SE, SG, TR, TW, VE |
| Quantity | 2,065 total |
| Model numbers | 470298, IS4000 |
Product
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: 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
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
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-2348-2016. 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.