Class 2 Device Recall da Vinci S, Si Mega Needle Driver Instrument

• Date Initiated by Firm: December 09, 2025
• Date Posted: March 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1698-2026
• Recall Event ID: 98383
• 510(K)Number: K050369
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 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
• Code Information: Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Device Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M10120217 SH0729 M10120301 SH0729 M10120412 SH0729 M10120507 SH0729 M10120525 SH0729 M20120530 SH0729 M10120703 SH0729 M10120724 SH0729 M10120803 SH0729 M10120810 SH0729 M10120827 SH0729 M10121025 SH0729 M10130102 SH0729 M10130212 SH0729 M10130213 SH0729 M10130314 SH0729 M10130418 SH0729 M10130517 SH0729 M10130603 SH0729 M10130606 SH0729 M10130617 SH0729 M10130701 SH0729 M10131014 SH0729 N10140430 SH0729 M10101206 SH0035 M10110624 SH0035 M10101206 SH1391 S10110307 SH1391 M10110302 SH1391 M10110701 SH1391 M10120404 SH1391 M10120705 SH1391 M10121010 SH1391 M10130118 SH1391 M10130125 SH1391 M10130515 SH1391 M10130626 SH1391 M10121206 SH1604 M10130308 SH1604 M10101127 SH0495 M10101217 SH0495 M10110131 SH0495 M10110512 SH0495 M10110817 SH0495 M10110901 SH0495 M10111008 SH0495 M20111221 SH0495 M10120217 SH0495 M10120224 SH0495 M10110527 SH0495 M10120727 SH0495 M10121004 SH0495 M10130102 SH0495 M10130213 SH0495 M10130301 SH0495 M10130812 SH0495 M10130924 SH0495 M10111201 SH1015 M10111208 SH1015 M10120217 SH1015 M10120425 SH1015 M10120618 SH1015 M10120713 SH1015 M10120823 SH1015 M10120827 SH1015 M10121022 SH1015 M10130212 SH1015 M10130213 SH1015 M10130828 SH1015 M10120831 SH1385 M10120918 SH1385 M10110412 SH2144 M10110706 SH2144 M10110923 SH2144 M10111008 SH2144 M10111205 SH2144 M20120103 SH2144 M10120210 SH2144 M10120713 SH2144 M10121121 SH2144 M10130325 SH2144 M10130529 SH2144 M10110302 SH0761 M10121129 SH0761 M10130719 SH0761 M10131001 SH0761 M20120322 SH1276 M10120525 SH1276 M10130503 USG518 M10130821 USG518 M10130828 USG518 M10131014 USG518 Material Number: 420194-10 Batch / System Numbers: N10170714 SH1182 N10170817 SH1182 N10171019 SH1182 M10140303 SH1570 N10140805 SH1570 N10150702 SH1570 N10160311 SH1570 N10160421 SH1570 N10161206 SH1570 N10161223 SH1570 N10180227 SG704 M10131121 SH0547 N10140609 SH0547 M10140221 SH0059 M10140307 SH0059 N10140508 SH0059 N10140827 SH0059 N10150320 SH0059 N10160519 SH0059 N10160728 SH0059 N11160907 SH0059 N11161013 SH0059 N10161129 SH0059 N10170419 SH0059 N11170407 SH0059 N10170612 SH0059 N10170705 SH0059 N10180202 SH0059 N10180323 SH0059 N10180321 SH0059 N10180412 SH0059 M10140225 SH1557 N10140605 SH1557 N10140620 SH1557 N10140827 SH1557 N12140929 SH1557 N10150211 SH1557 N10150320 SH1557 N10150528 SH1557 N10150616 SH1557 N10150721 SH1557 N10151209 SH1557 N10160307 SH1557 N10160519 SH1557 N10160509 SH1557 N10160728 SH1557 N10160907 SH1557 N10161031 SH1557 N11170111 SH1557 N11161216 SH1557 N11170427 SH1557 N10170504 SH1557 N10170605 SH1557 N10170914 SH1557 N10171016 SH1557 N10171027 SH1557 N10180118 SH1557 N10180223 SH1557 N10180321 SH1557 N10180427 SH1557 N10150604 SH1964 N10150626 SH1964 N10151207 SH1964 N10151211 SH1964 N10180131 SH1964 N10180223 SH1964 N10180404 SH1964 N10180426 SH1964 N10150814 SH1837 N10160105 SH1837 N10160728 SH1837 N11160901 SH1837 N10150717 SH1390 N10160419 SH1390 M10131211 USG689 N10160519 USG689 M10140515 SH1368 N11141113 SH1368 N10160105 SH1368 N10160718 SH1368 N10170901 SH1368 M10131102 USG294 M10140107 USG294 M10140109 USG294 M10140221 USG294 M10140408 USG294 N10140516 USG294 N10140923 USG294 N10141016 USG294 N10150219 USG294 N10150325 USG294 N10150723 USG294 N10151002 USG294 N10151013 USG294 N10160104 USG294 N10160307 USG294 N10160504 USG294 N11160616 USG294 N11160720 USG294 N10160907 USG294 N11160923 USG294 N10161118 USG294 N10161207 USG294 N10170302 USG294 N10170421 USG294 N10170621 USG294 N10170817 USG294 N10170927 USG294 N10180202 USG294 N10171214 USG294 N10180131 USG294 M10140324 SH2186 N10141127 SH2186 N10150320 SH2186 N10150626 SH2186 N10150731 SH2186 N10160901 SH2186 N10170427 SH2186 N10170509 SH2186 N10171221 SH2186 N10180321 SH2186 N11161207 SH0825 N10170511 SH0825 N10180301 SH0825 M10131109 SH1378 M10131104 SH0935 M10140225 SH0935 N10140718 SH0935 M10131109 SH0729 M10131130 SH0729 M10131202 SH0729 M10140107 SH0729 N10140611 SH0729 N10140716 SH0729 N10140717 SH0729 N10140728 SH0729 N10140826 SH0729 N11140929 SH0729 N10141118 SH0729 N10141205 SH0729 N10150219 SH0729 N10150226 SH0729 N10150421 SH0729 N10150428 SH0729 N10150721 SH0729 N10150804 SH0729 N10151123 SH0729 N10151203 SH0729 N10160311 SH0729 N11160419 SH0729 N11160907 SH0729 N10161019 SH0729 N10170324 SH0729 N11170410 SH0729 N10170511 SH0729 N10170621 SH0729 N10170810 SH0729 N10171207 SH0729 N10180202 SH0729 N11171214 SH0729 N11180321 SH0729 N10180307 SH0729 N10180412 SH0729 N10140722 SH0035 N10140910 SH0035 N10150519 SH0035 N10150707 SH0035 N11160711 SH0035 N10160804 SH0035 N10170207 SH0035 N10170511 SH0035 N10171207 SH0035 M10131121 SH1391 M10131217 SH1391 N10140516 SH1391 M10140206 SH2125 N10140530 SH2125 N10140611 SH2125 N10140926 SH2125 N10150105 SH2125 N10150413 SH2125 N10150504 SH2125 N10150804 SH2125 N10150918 SH2125 N10150928 SH2125 N10160114 SH2125 N10160504 SH2125 N10160519 SH2125 N10160601 SH2125 N10161019 SH2125 N10161216 SH2125 N10170404 SH2125 N10161025 SH2125 M10131104 SH2125 N10170712 SH2125 N10171103 SH2125 N11171214 SH2125 N10180223 SH2125 N10150818 SH2125 N10180323 SH2125 N10180321 SH2125 N10180427 SH2125 N10160219 SH1076 N10170427 SH1076 M10140116 SH1604 N10170926 SH1604 N10180122 SH1604 N10180111 SH1604 M10140121 SH0495 M10140303 SH0495 N10140522 SH0495 N10140808 SH0495 N11141112 SH0495 N10141127 SH0495 N11141205 SH0495 N10150226 SH0495 N10150626 SH0495 N10150811 SH0495 N10160523 SH0495 N10160822 SH0495 N11160822 SH0495 N10161118 SH0495 N10170301 SH0495 N10170927 SH0495 N10180202 SH0495 M10131119 SH1015 M11140109 SH1015 M10140131 SH1015 M10140307 SH1015 N10140425 SH1015 N10140708 SH1015 N10140904 SH1015 N11140902 SH1015 N10150204 SH1015 N10150211 SH1015 N10150216 SH1015 N10150511 SH1015 N10150610 SH1015 N10150630 SH1015 N10150707 SH1015 N10150828 SH1015 N10150916 SH1015 N10150928 SH1015 N10160212 SH1015 N10160229 SH1015 N10160307 SH1015 N10160330 SH1015 N10160504 SH1015 N10160610 SH1015 N10160616 SH1015 N10160630 SH1015 N10160706 SH1015 N11160711 SH1015 N10160822 SH1015 N11160907 SH1015 N10160901 SH1015 N11161013 SH1015 N11161118 SH1015 N10161118 SH1015 N10161223 SH1015 N10170202 SH1015 N10170302 SH1015 N10170316 SH1015 N11170324 SH1015 N10170331 SH1015 N10170504 SH1015 N10170511 SH1015 N10170515 SH1015 N10170623 SH1015 N10170710 SH1015 N10170720 SH1015 N10170901 SH1015 N10171003 SH1015 N10171103 SH1015 N10180312 SH1015 N10171221 SH1015 N10180122 SH1015 N10171226 SH1015 N10180124 SH1015 N10180227 SH1015 N10180426 SH1015 N10180412 SH1385 M10140303 SH2144 M10140326 SH2144 N10140605 SH2144 N10140805 SH2144 N10150223 SH2144 N10160519 SH2144 N10170913 SH2144 N10150312 SH0761 N10150528 SH0761 M10140206 SH1276 M10140213 SH1276 M10140327 SH1276 N10140508 SH1276 N10140925 SH1276 N10150305 SH1276 N10151021 SH1276 N10151125 SH1276 N10140902 USG518 N12140929 USG518 N10141008 USG518 M10140108 USG518 N10150320 USG518 N10161111 USG518 N10170103 USG518 Material Number: 420194-12 Batch / System Numbers: N10190729 SH1182 N10180921 SH1557 N10190104 SH1557 N10190211 SH1557 N10190326 SH1557 N12190423 SH1557 N10190719 SH1557 N11191021 SH1557 N10191216 SH1557 N10210329 SH1557 N10210524 SH1557 N10210517 SH1557 N10190108 SH1837 N10200727 SH1837 N10201012 SH1837 N10201103 SH1837 N10210412 SH1837 N10191111 USG689 N10191125 USG689 N10190805 SH1368 N10190930 SH1368 N10180808 USG294 N10180906 SH2186 N10190522 SH2186 N10201012 SH2186 N10190226 SH0825 N10190326 SH0825 N10210412 SH0825 N10181126 SH0729 N10190107 SH0729 N10190212 SH0729 N10180814 SH2125 N10180815 SH2125 N10181008 SH2125 N10190107 SH2125 N10190212 SH2125 N10190327 SH2125 N10190729 SH2125 N10191111 SH1076 N10180808 SH1604 N10190930 SH1604 N10190108 SH0495 N10190805 SH0495 N10190930 SH0495 N10200727 SH0495 N10180814 SH1015 N10180813 SH1015 N10181017 SH1015 N10190107 SH1015 N10190108 SH1015 N10190307 SH1015 N10190308 SH1015 N10190522 SH1015 N10190805 SH1015 N10190923 SH1015 N10190917 SH1015 N10191111 SH1015 N11191202 SH1015 N10191216 SH1015 N10191125 SH1015 N10191021 SH1015 N10200810 SH1015 N10201103 SH1015 N10210802 SH1015 N10181024 SH1385 N10191111 SH1385 N10190107 SH1279 N10190212 SH1279 N10190327 SH1279 N10210607 SH1279 Material Number: 420194-13 Batch / System Numbers: K11220626 SH1964 K10220228 SH1837
• FEI Number: 3001675293
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd; Sunnyvale CA 94086-5304
• For Additional Information Contact: Shahbaz Khan; 1-408-5232443
• Manufacturer Reason for Recall: Due to increased complaints for broken/frayed grip cables for reusable instruments.
• FDA Determined Cause: Process control
• Action: 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)
• Quantity in Commerce: 7819
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY