---
title: "Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm — FDA record Z-0406-2024 | Is It on Recall"
description: "There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement."
url: https://isitonrecall.com/recall/fda-device-z-0406-2024-da-vinci-single-site-wristed-needle-driver-ref-478115-5-mm/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm — FDA record Z-0406-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
- **Reason**: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
- **Classification**: Class II
- **Recalling firm**: Intuitive Surgical, Inc.
- **Quantity**: 317 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0406-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0406-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Dec 6, 2023
- **Recall initiation date**: Oct 6, 2023
- **Center classification date**: Nov 28, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0406-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Intuitive Surgical, Inc. records](https://isitonrecall.com/brand/intuitive-surgical-inc/)