Recall Z-1701-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA 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
| Date | Mar 30, 2026 (initiated Dec 9, 2025) |
| Status | Open, Classified |
| Reason | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments |
| Root cause | Process change control |
| Action | On 12/29/2025, the firm email and sent via overnight priority mail an "Urgent: Medical Device Recall" letter to customers informing them of possible pitch cable failures on the da Vinci S and Si Tenaculum Forceps and Permanent Cautery Hooks reusable instruments. Customers are instructed to: 1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 2. Please 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 c |
| Quantity | 6152 instruments |
| Distribution | U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Gua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |