Intuitive Surgical, Inc. recalls Brand Name: da Vinci S

Recalling company

Intuitive Surgical, Inc.

Product

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 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 accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Reason

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 9, 2025

Reported

Apr 8, 2026

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, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Status

Ongoing

Quantity

2370

Lot / codes

Lot Code: 420189, Double Fenestrated Grasper GTIN: 00886874111581 FDA Medical Device Listing Number: D088920 Material Number: 420189-07 Batch / System Numbers: M10120911 SH1182 M10130103 SH1182 M10130116 SH1182 M10130124 SH1182 M10130422 SH1182 M10130731 SH1182 M10130918 SH1182 M10110112 SG704 M10110202 SG704 M10110318 SG704 M10111028 SG704 M20111221 SG704 M10120220 SG704 M10120419 SG704 M10130110 SG704 M10130422 SG704 M10130726 SG704 M10130802 SG704 M10130802 SH0547 M10130918 SH0547 M10110808 SH0059 M10111027 SH0059 M10111104 SH0059 M10121123 SH0059 M10121213 SH0059 M10130103 SH0059 M10130815 SH1557 M10130625 SH1390 M10130731 SH1390 M10130802 SH1390 M10130603 USG721 M10120911 SH0825 M10120727 SH1378 M10121026 SH1378 M10121105 SH1378 M10130121 SH1378 M10130207 SH1378 M10130218 SH1378 M10130322 SH1378 M10130315 SH1378 M10130422 SH1378 M10130603 SH1378 M10130625 SH1378 M10130726 SH1378 M10131010 SH1378 M10110309 SH0729 M10110415 SH0729 M10110621 SH0729 M10110812 SH0729 M10121009 SH0729 M10130103 SH0729 M10130124 SH1622 M10120125 SH1076 M10121113 SH1076 M10130426 SH1604 M10120719 SH1385 M10120727 SH1385 M10120822 SH1385 M10120829 SH2144 M10111104 SH0761 M10120327 SH1276 M10120522 SH1276 M10121026 SH1276 M10130514 SH1276 M10130426 USG518 M10130829 USG518 Material Number: 420189-09 Batch / System Numbers: M10131104 SH1182 M10140228 SH1182 M10140414 SH1182 N10140508 SH1182 N10140619 SH1182 N10140703 SH1182 N10140812 SH1182 N10140902 SH1182 N10141204 SH1182 N10150430 SH1182 N101

Company location

Sunnyvale, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1697-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1697-2026 in the FDA Enforcement Report. Also see FDA recall press releases.