FDA Device recall Z-2381-2018
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box by Intuitive Surgical, citing intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2381-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-23 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
Product
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Reason
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Identifiers
| code_info | UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020 |
|---|
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-2381-2018%22
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