—#218536

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369
Affected lot / code info: 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 N10150814 SH1182 N10150916 SH1182 N10151106 SH1182 N10151119 SH1182 N10160429 SH1182 N10160520 SH1182 N10150825 SH1182 N10160617 SH1182 N10160914 SH1182 N10161012 SH1182 N10161222 SH1182 N10160908 SH1182 N10180105 SH1182 N10140521 SG704 N10140801 SG704 N10141017 SG704 N10150309 SG704 N10150526 SG704 N10150805 SG704 N10160106 SG704 N10160429 SG704 N10160425 SG704 N10160901 SG704 N10170330 SG704 N10171116 SG704 N10171121 SG704 N10150219 SH0547 N10160408 SH0547 M10140324 SH0059 N10140902 SH0059 N10141121 SH0059 N10150227 SH0059 N10150409 SH0059 N10150626 SH0059 N10160901 SH0059 N10160914 SH0059 N10161012 SH0059 N10161122 SH0059 N10171212 SH0059 N10150416 SH1557 N10150727 SH1557 N10160229 SH1557 N10151201 SH1557 N10160520 SH1557 N10160817 SH1557 N10161012 SH1557 N10161122 SH1557 N10170130 SH1557 N10170210 SH1557 N10160825 SH1557 N10170515 SH1557 N10170815 SH1557 N10171116 SH1557 N10171121 SH1557 N10180105 SH1557 M10131108 SH1390 N10141017 SH1390 N10170825 SH1368 N10160525 USG721 N10160808 USG721 M10140327 SH2186 N10140902 SH0825 N10141027 SH0825 N10160114 SH0825 N10161027 SH0825 N10171116 SH0825 M10131025 SH1378 M10131104 SH1378 M10140214 SH1378 M10140324 SH1378 N10140508 SH1378 N10140902 SH1378 N10141030 SH1378 N10141204 SH1378 N10160203 SH1378 N10170330 SH1378 M10140325 SH0729 N10140711 SH0729 N10150122 SH0729 N10150910 SH0729 N10151217 SH0729 N10160509 SH0729 N10160216 SH0035 N10170609 SH0035 M10140327 SH2125 N10140603 SH2125 N10160718 SH2125 N10161209 SH2125 N10171019 SH1604 N10171220 SH1604 N10170531 SH1279 N10170609 SH1279 N10170628 SH1279 N10140711 SH2144 N10150129 SH2144 N10150526 SH2144 N10150727 SH2144 N10151119 SH2144 N10160914 SH2144 N10161222 SH2144 N10171204 SH2144 M10140414 SH1276 N10140603 SH1276 N10150129 USG518 Material Number: 420189-10 Batch / System Numbers: N10180409 SH1182 N10180702 SH1182 N10180509 SG704 N10180223 SH1557 N10180712 SH1557 N12180123 SH0825 N10180409 SH1279 Material Number: 420189-11 Batch / System Numbers: N10190128 SH1182 N10190206 SH1182 N10180814 SH1557 N10181005 SH1557 N10180802 SH1557 N10180928 SH1557 N10190423 SH1557 N10190902 SH1557 N10180814 SH0825 N10190805 SH0825 N10190306 SH2180 N10190128 SH1604 N10180814 SH2144 Material Number: 420189-12 Batch / System Numbers: N10190715 SH1182 N10190502 SH1182 N10190513 SH1182 N10190513 SH1557 N10190408 SH1557 N10190715 SH1557 N10200217 SH1557 N10200803 SH1557 N10201005 SH1557 N10210419 SH1557 N10210210 SH1557 N10200217 SH1964 N10200720 SH1964 N10200427 SH1964 N10210419 SH1964 N10210308 SH1964 N10210713 SH1964 N10200427 SH1604 N10210104 SH1604 N10190502 SH1385 N10210913 SH2144 K10220925 SH2144 K10231026 SH2144

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

On 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 to include the FSCA number ISIFA2025-15-R in the return notes. 4. Credit will be provided based on the number of remaining lives. 5. Shared or further distributed these products with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product. For questions or concern, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-12-09
Posted by FDA: 2026-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.