Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 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 and placement of...
- Reason
- Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical 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
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c25c16a2-d1f9-47ac-aadf-49cc4a8b54e8