Intuitive Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1325-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

Product Classification:

Class II

Date Initiated: February 26, 2025
Date Posted: March 19, 2025
Recall Number: Z-1325-2025
Event ID: 96345
Reason for Recall:

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Status: Ongoing
Product Quantity: 439 units
Code Information:

UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the country of South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated