Class II — Potential Health Hazard

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

EndoWrist One Vessel Sealer used in conjunction with the da Recalled by Intuitive Surgical, Inc. Due to Intuitive Surgical is initiating a voluntary correction relating...

Date: September 17, 2014
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

EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

Quantity: 1,483 devices

Why Was This Recalled?

Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.

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