Recall Z-1325-2025— Intuitive Surgical, Inc.

Name: FDA recall Z-1325-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-26

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2025-02-26. It names one FDA 510(k) clearance: K232610. Product: 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. Reason: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed.

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-26
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc.·cleared 2024-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.