Intuitive Surgical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0406-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 6, 2023

Date Posted: December 6, 2023

Recall Number: Z-0406-2024

Event ID: 93301

Reason for Recall:

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

Status: Ongoing

Product Quantity: 317 units

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated