# FDA recall Z-2310-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2026-04-24.

## Product

Brand Name: Da Vinci 5  Product Name: ASSY,DV5 TOWER,IS5000  Model/Catalog Number: 380746  Software Version: N/A  Product Description: Preface:   This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description  in this report references the NIR handheld camera system.    Product Description:   The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in  surgery. The components of the NIR handheld camera system include a camera control unit  and a light source, NIR handheld camera, and additional components that together, connect  to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from  the NIR handheld camera system is displayed on the Tower monitor.  Component: Yes, the SOCK is the component and integrated into the dV5 system

## Reason for recall

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.  O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom

## Key facts

- **Recall number:** Z-2310-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-24
- **Report date:** 2026-06-10

- **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-2310-2026

## Citation

> MORVS. FDA recall Z-2310-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2310-2026. Source: US FDA. Licensed CC0.

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