Recall Z-1355-2026— Intuitive Surgical, Inc.

Name: FDA recall Z-1355-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-30

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2025-12-30. It names one FDA 510(k) clearance: K232610. Product: da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45. Reason: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-30
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 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45

Reason for recall

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

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