Intuitive Surgical, Inc.: Device Recall

Recall #Z-1325-2025 · 02/26/2025

Class II: Risk

Recall Details

Recall Number
Z-1325-2025
Classification
Class II
Product Type
Device
Recalling Firm
Intuitive Surgical, Inc.
Status
Ongoing
Date Initiated
02/26/2025
Location
Sunnyvale, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
439 units

Reason for Recall

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

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

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.

Other Recalls by Intuitive Surgical, Inc.

View all recalls by Intuitive Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.