Intuitive Surgical Recalls

12 recalls found for Intuitive Surgical. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Display Over High Injury Risk

Intuitive Surgical recalled 47 da Vinci 5 Surgeon Console Viewer Displays on December 30, 2025. The devices may lose display functionality, risking surgical injury. Healthcare providers should stop using the consoles immediately and follow recall instructions.

Intuitive Surgical
Robotic-assisted surgical
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci SP Access Port Kits Over Sterility Risk

Intuitive Surgical recalled 41,526 da Vinci SP Access Port Kits on December 15, 2025, due to potential cracks in the tray that could breach sterility. The recall affects models 430073 and 430075, distributed worldwide including across the US and various countries. Patients and healthcare providers must stop using these devices immediately and follow manufacturer instructions for return.

Intuitive Surgical
Access Port
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si Monopolar Curved Scissors Recall for 86,904 Units Worldwide (2025)

Intuitive Surgical recalled 86,904 da Vinci S and Si Monopolar Curved Scissors instruments sold worldwide to hospitals and surgical centers. The recall cites increased complaints of broken or frayed grip cables on reusable instruments. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si Mega Needle Driver Instrument Recall 7,819 Units Worldwide (2026)

Intuitive Surgical recalled 7,819 units of the da Vinci S/Si Mega Needle Driver Instrument sold worldwide to hospitals and healthcare providers. The recall cites broken or frayed grip cables that can impair instrument control. Stop using the device and follow the manufacturer’s recall instructions for replacement or service.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls 2,095 da Vinci S, Si EndoWrist Tenaculum Forceps Instrument (2025)

Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si EndoWrist Recall 6,152 Instruments for Pitch Cable Frays (2026)

Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S, Si Grasping Retractor Instrument Recalled for 2,660 Units (2026)

Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls Ion Vision Probe Bag Over Sterility Risk

Intuitive Surgical recalled 110,580 Ion Vision Probe Bags on December 4, 2025, due to compromised sterile seals. The recall affects devices distributed throughout the United States and several countries including Australia and Germany. Patients and healthcare providers should stop using the product immediately.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls Da Vinci 5 Console Over Software Error

Intuitive Surgical recalled 12 Da Vinci 5 surgical consoles on November 17, 2025. A software error may cause loss of user interface content on external monitors. Healthcare providers must stop using the devices immediately.

Intuitive Surgical
An error
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Health & Personal Care
HIGH
FDA DEVICE

Da Vinci Surgical Systems Recalled Due to Diagnostic Software Flaw

Intuitive Surgical recalled 219 da Vinci surgical systems on November 7, 2025, due to a software error. This error allowed malfunctioning instrument arms to remain in clinical use, posing a high risk of failure. Healthcare providers and patients must stop using these systems immediately.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Console Motor Connector Due to High Hazard

Intuitive Surgical recalled 144 units of the da Vinci 5 Surgeon Console Column Motor Connector on August 21, 2024. Users reported a potential ergonomic lock issue that could delay or abort surgical procedures. Healthcare providers must stop using the devices immediately and follow the recall instructions.

Intuitive Surgical
Surgical system
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Brand Statistics

Total Recalls
12
Pages
1