# FDA recall Z-2046-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2026-04-02.

## Product

Brand Name: Da Vinci X and Da Vinci Xi  Product Name: da Vinci X,  Xi Surgical System  Model/Catalog Number: IS4000; IS4200  Software Version: N/A  Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery.  Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

## Reason for recall

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN,  KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX,  UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador,  Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2046-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-02
- **Report date:** 2026-05-13

- **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-2046-2026

## Citation

> AI Analytics. FDA recall Z-2046-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2046-2026. Source: US FDA. Licensed CC0.

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