Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ion Endoluminal System Recalled by Intuitive Surgical, Inc. Due to There is a potential that the robotic system's...
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
Ion Endoluminal System, REF: 380748-65
Quantity: 3 units
Why Was This Recalled?
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
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