Intuitive Surgical
12 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Intuitive Surgical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IIStop using affected da Vinci cautery hook instruments
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- 2026-04-08FDA-DeviceClass IICheck da Vinci Tenaculum Forceps for cable damage
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- 2026-04-08FDA-DeviceClass IIStop using affected da Vinci grasping retractors
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- 2026-04-08FDA-DeviceClass IIStop using da Vinci Mega Needle Driver instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- 2026-04-08FDA-DeviceClass IIStop using affected da Vinci grasper instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- 2026-04-08FDA-DeviceClass IIStop using recalled da Vinci scissors instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- 2026-02-25FDA-DeviceClass IICheck your Da Vinci 5 console software version
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.
- 2026-02-18FDA-DeviceClass IIContact Intuitive Surgical about da Vinci 5 display firmware
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
- 2026-02-11FDA-DeviceClass IICheck da Vinci surgical system instrument arms
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
- 2026-01-28FDA-DeviceClass IICheck your Ion Vision Probe Bag lot number
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
- 2026-01-21FDA-DeviceClass IICheck da Vinci SP Access Port Kit lot numbers
Access Port System tray may develop cracks potentially resulting in a sterility breach.
- 2025-12-31FDA-DeviceClass IICheck your da Vinci 5 surgeon console serial number
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
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