Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thyroidectomy Indication for the da Vinci Surgical Systems Recalled by Intuitive Surgical, Inc. Due to Promotional literature for use of the da Vinci...
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
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.
Quantity: 2,423 consignee
Why Was This Recalled?
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report