Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
User Manual addendum Recalled by Intuitive Surgical, Inc. Due to Change to User Manual to remove one indication...
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
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Quantity: 1,374
Why Was This Recalled?
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Where Was This Sold?
US Distribution Only
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