FDA Device recall Z-0406-2024
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm by Intuitive Surgical, citing there is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0406-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-06 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | CA, CO, FL, ID, IL, MI, MS, NJ, NY, OR, PR, SC, TN, TX |
Product
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Reason
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Identifiers
| code_info | UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220…UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109 |
|---|
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-0406-2024%22
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