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CLASS II · ModerateFDA

Intuitive Surgical, Inc. recalls Da Vinci 5 ASSY

📅 Nov 17, 2025 · 📍 LA, MA, NY, PA, TX, VA
Recalling company
Intuitive Surgical, Inc.
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 17, 2025
Reported
Feb 25, 2026
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
Status
Ongoing
Quantity
12
Lot / codes
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Company location
Sunnyvale, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-1428-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1428-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.