# FDA recall Z-0406-2024

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2023-10-06.

## Product

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

## Reason for recall

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

## Distribution

US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

## Key facts

- **Recall number:** Z-0406-2024
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-06
- **Report date:** 2023-12-06

- **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-0406-2024

## Citation

> AI Analytics. FDA recall Z-0406-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0406-2024. Source: US FDA. Licensed CC0.

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