Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Da Vinci Single-Site Wristed Needle Driver Recalled by Intuitive Surgical, Inc. Due to There is the potential for the needle drive...

Date: October 6, 2023
Company: Intuitive Surgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.

Affected Products

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

Quantity: 317 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 13 states: CA, CO, FL, ID, IL, MI, MS, NJ, NY, OR, SC, TN, TX

Affected (13 states)Not affected

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report