Medical device recalls Moderate risk

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

Recall date
November 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1428-2026
FDA classification
Class II
Brand / firm
Intuitive Surgical, Inc.
Sold / distributed
US distribution: LA, MA, NY, PA, TX, and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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