STAPLER — Class II medical device recall Z-1726-2017
Terminated recall by Intuitive Surgical, Inc., reported 2017-04-12, distributed nationwide. Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instruc
| Recall number | Z-1726-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2017-03-15 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IT, JP, KR, LU, NL, NO, PT, SE, SG, TR, TW, VE |
| Quantity | 2,059 shipped |
| Model numbers | 381395-01, 470298, IS4000 |
Product
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic Surgery: The Intuitive Surgical 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
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
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-1726-2017. 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.