Intuitive Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1426-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.

Product Classification:

Class II

Date Initiated: October 13, 2011

Date Posted: June 5, 2013

Recall Number: Z-1426-2013

Event ID: 65072

Reason for Recall:

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

Status: Terminated

Product Quantity: 2,423 consignee

Code Information:

NA - marketing and promotional only.

Distribution Pattern:

USA Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated