Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument

Recalling firm
Intuitive Surgical, Inc.
Product
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery...
Reason
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2025-12-09
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy,...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/020c2626-843a-4d95-a8ed-c4d8482b906b