# FDA recall Z-1428-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2025-11-17.

## Product

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

## 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.

## Distribution

US distribution: LA, MA, NY, PA, TX, and VA.

## Key facts

- **Recall number:** Z-1428-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-17
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2026

## Citation

> AI Analytics. FDA recall Z-1428-2026. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-1428-2026. Source: US FDA. Licensed CC0.

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