Intuitive Surgical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1262-2023)

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:

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

Product Classification:

Class II

Date Initiated: January 24, 2023

Date Posted: March 22, 2023

Recall Number: Z-1262-2023

Event ID: 91505

Reason for Recall:

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Status: Ongoing

Product Quantity: 9

Code Information:

System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France

Voluntary or Mandated:

Voluntary: Firm initiated