Home / Recalls / Intuitive Surgical, Inc. / Z-0406-2024

Z-0406-2024 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
December 6, 2023
Initiation Date
October 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
317 units

Product Description

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Reason for Recall

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Distribution Pattern

US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

Code Information

UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

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  • Z-1428-2026 Class II — Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used fo (November 17, 2025)