Recall Z-1428-2026— Intuitive Surgical, Inc.

Name: FDA recall Z-1428-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-17

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2025-11-17. It names one FDA 510(k) clearance: K232610. Product: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.. Reason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-17
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

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

Reason for recall

An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

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