Intuitive Surgical recalls

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Moderate·FDA·Jul 22, 2026

Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

Serious·FDA·Jul 1, 2026

Intuitive Surgical is recalling two da Vinci S and Si reusable surgical instruments, totaling 8,247 units, after the company received complaints of frayed or broken pitch cables. The products were distributed across the U.S. and in many other countries. No injuries have been reported.

Moderate·FDA·Apr 8, 20262 products

Intuitive Surgical is recalling four reusable instrument models used with da Vinci S and Si robotic surgical systems. The company received increased complaints of broken or frayed grip cables. No injuries have been reported, and the instruments were distributed in the U.S. and in many other countries.

Moderate·FDA·Apr 8, 20264 products

A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.

Moderate·FDA·Feb 25, 2026

Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.

Serious·FDA·Feb 18, 2026

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

Moderate·FDA·Feb 11, 2026

Intuitive Surgical has recalled certain Ion Vision Probe Bags (model 490127) because the sterile pouch seal may be compromised or incomplete. These bags are used to store the Vision Probe during lung biopsy procedures. A compromised seal could allow contamination of the sterile device.

Moderate·FDA·Jan 28, 2026

Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.

Moderate·FDA·Jan 21, 2026

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.

Moderate·FDA·Dec 31, 2025