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
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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.
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