Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: 12 recalls listed since January 2026 across FDA; 1 rated high risk.
By year
- 202612
By agency
- FDA12
By category
- Medical Device12
All recalls (12)
Intuitive Surgical da Vinci SP Instrument Arm Drape
The da Vinci SP Instrument Arm Drape may detach from the instrument arm, exposing a section and causing procedure delay or conversion.
Intuitive Surgical Da Vinci PSS SP1098
The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.
Da Vinci 5
The Da Vinci 5 system tower can unintentionally activate its near infrared handheld camera when turning off illumination.
Da Vinci X, Xi Surgical System
The da Vinci X and Xi surgical systems have screws in the arm that may break.
Intuitive 8 mm SureForm 30 Gray Reloads
The reloads may potentially produce an incomplete staple line.
Intuitive Surgical da Vinci S and Si Endoscopic Instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
4 products
Intuitive Surgical da Vinci S, Si Tenaculum Forceps and Permanent Cautery Hook Instruments
The da Vinci S, Si Tenaculum Forceps Instrument has frayed or broken pitch cables.
2 products
Intuitive Surgical Da Vinci 5 Console
The Da Vinci 5 surgical system can have an error event causing loss of user interface content on a monitor.
Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display
The da Vinci 5 Surgeon Console Viewer Display has outdated firmware that may cause loss of 3D or complete visualization, potentially leading to injury.
Da Vinci X, Xi, and 5 Surgical Systems
The da Vinci surgical systems have a software error that can allow failing instrument arms to remain in use.
Intuitive Surgical Ion Endoluminal System Vision Probe Bags
The Ion Vision Probe Bag may have a compromised or incomplete sterile pouch seal.
Intuitive Surgical da Vinci SP Access Port Kit
The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.
