Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
da Vinci Xi Surgical System Model IS4000 da Vinci X Recalled by Intuitive Surgical, Inc. Due to Due to Universal Surgical Manipulator (USM) instrument carriage...
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
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Quantity: 1,225 total USMs
Why Was This Recalled?
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Where Was This Sold?
U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam
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