# FDA recall Z-0340-2023

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2022-10-07.

## Product

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530    INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X  REF 48230M    INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W    INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

## Reason for recall

Potential staple deployment failure and device fragment generation

## Distribution

U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.  O.U.S.: None

## Key facts

- **Recall number:** Z-0340-2023
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-07
- **Report date:** 2022-12-07

- **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-0340-2023

## Citation

> AI Analytics. FDA recall Z-0340-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0340-2023. Source: US FDA. Licensed CC0.

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