# FDA recall Z-1697-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2025-12-09.

## Product

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument  Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument  Model/Catalog Number: 420189  Software Version: NA  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient)

## Reason for recall

Due to increased complaints for broken/frayed grip cables for reusable instruments.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

## Key facts

- **Recall number:** Z-1697-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-09
- **Report date:** 2026-04-08

- **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-1697-2026

## Citation

> AI Analytics. FDA recall Z-1697-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1697-2026. Source: US FDA. Licensed CC0.

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