# FDA recall Z-1096-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2025-12-15.

## Product

da Vinci  SP, SP Access Port Kit, Large Incision    Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

## Reason for recall

Access Port System tray may develop cracks  potentially resulting in a sterility breach.

## Distribution

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-1096-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-15
- **Report date:** 2026-01-21

- **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-1096-2026

## Citation

> AI Analytics. FDA recall Z-1096-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1096-2026. Source: US FDA. Licensed CC0.

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