← FDA ENFORCEMENT
Z-1428-2026Class II

Intuitive Surgical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Intuitive Surgical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-02-25
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
Firm state
CA
Product quantity
12
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
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.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →