Intuitive Surgical recalled 2,370 units of the da Vinci S, Si Double Fenestrated Grasper Instrument distributed worldwide on December 9, 2025. The EndoWrist instruments use mechanical cables to transmit motion. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The da Vinci S/Si EndoWrist instruments are reusable robotic surgery tools used to manipulate tissue during procedures. They rely on mechanical cables to transmit motion from input discs to the distal tip.
A broken or frayed grip cable can compromise instrument control during surgery, potentially affecting performance and precision.
This recall is not described as part of a broader industry pattern.
Hospitals may need to quarantine affected instruments and arrange replacements, potentially delaying procedures and increasing administrative burden.
Official recall notices on FDA enforce pages and Intuitive Surgical patient safety communications.
Replacement or repair arrangements will be communicated by the manufacturer; typical timelines vary by hospital supply chain.
Keep recall notification, hospital correspondence, device batch codes, and replacement records for audits and claims.
Brand: Intuitive Surgical. Product: da Vinci S/Si Double Fenestrated Grasper Instrument. Model/Catalog Number: 420189. Software Version: NA. Quantity recalled: 2370. Distribution: Worldwide, including CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI; Countries listed in recall. Recall date: 2025-12-09. Status: ACTIVE. Hazard: Broken or frayed grip cables. Manufacturer: Intuitive Surgical, Inc.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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 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 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 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 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 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 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 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.