Class II — Potential Health Hazard

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

IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System Recalled by Intuitive Surgical, Inc. Due to Revised instructions for users of the da Vinci...

Date: March 15, 2013
Company: Intuitive Surgical, Inc.
Status: Terminated
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

IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.

Quantity: 1642 customers

Why Was This Recalled?

Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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