FDAClass IIFebruary 25, 2026

Da Vinci 5 ASSY recall: Software Issue

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

Why was Da Vinci 5 ASSY 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Recalling firm
Intuitive Surgical, Inc.
Quantity
12
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
Recall date
February 25, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls