FDA Device recall Z-0404-2018
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Sta…
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Sta… by Intuitive Surgical, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0404-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-19 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0404-2018%22
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