Class II — Potential Health Hazard

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

The da Vinci SP surgical system is made of three Recalled by Intuitive Surgical, Inc. Due to The firm became aware of a problem with...

Date: October 23, 2018
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

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.

Quantity: 5 PSCs (Units)

Why Was This Recalled?

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

Where Was This Sold?

Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.

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