FDA Device recall Z-2059-2023
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 by Intuitive Surgical, citing fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2059-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Reason
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Identifiers
| code_info | UDI-DI: 00886874112496, All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2023%22
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