ClearanceBrief
Recall Z-1696-2026 ยท NAY System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

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, electroc

DateMar 30, 2026 (initiated Dec 9, 2025)
StatusOpen, Classified
ReasonDue to increased complaints for broken/frayed grip cables for reusable instruments.
Root causeProcess control
ActionOn 12/29/2025, the firm sent via email an "Urgent: Medical Device Recall" Letter informing customers that intuitive has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci S and Si reusable instruments. Customers are instruct to: 1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 2. Identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service. 3. Ensure t
Quantity86904
DistributionWorldwide - 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, Japan,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
Intuitive Surgical, Inc., Apr 29, 2005
K1800338mm Monopolar Curved Scissors
Intuitive Surgical, Inc., Apr 6, 2018