The FDA has posted 56 enforcement recalls from Intuitive Surgical, Inc. since 2025, including 1 Class I (most serious) recall. Most recent report: Jul 1, 2026.
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled moti…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic end…
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete…
Firm name as filed with the FDA: “Intuitive Surgical, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.