daVinci X EndoWrist — Class II medical device recall Z-0404-2018
Terminated recall by Intuitive Surgical, Inc., reported 2018-01-31, distributed nationwide. Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufactu
| Recall number | Z-0404-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2017-09-19 |
| Classified | 2018-01-23 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2024-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 60 units |
| UPC / GTIN / UDI-DI | 00886874112427 |
| Serial numbers | S10170630, S10170707, S10170731, S11170705 |
| Model numbers | 470298, IS4000 |
Product
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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 the same staple line or tissue buttressing material (natural synthetic).
Reason for recall
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
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-0404-2018. 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.