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RecallWatchMedical Device Safety
Class IIOngoingZ-1698-2026

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

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Apr 8, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    GTIN 00886874111611
    400 affected lots
    42019400886874111611D088920420194-08M10120201SH1182M20120412SH1182
    +392 moreM10130121SH1570M10130306SH1570M10110602SH0547M10110627SH0547M10121129SH0059M10121214SH0059M10130429SH0059M10130521SH0059M10121105SH1557M10130517SH1837M10121109SH1390M10130508SH1390M10131004SH1390M10130306USG689M10130412USG689M10110302SH1368M10110614SH1368M10110620SH1368M10110817SH1368M10120705SH1368M10121022SH1368M10130429SH1368M10130509SH1368M10130722SH1368M10110131USG294M10110511USG294M10110616USG294M10110811USG294M10111003USG294M20111103USG294M10111206USG294M20120103USG294M10120130USG294M10120305USG294M10120425USG294M10120713USG294M10121004USG294M10121017USG294M10121022USG294M10121105USG294M10121107USG294M10121206USG294M10121207USG294M10130108USG294M10130112USG294M10130201USG294M10130213USG294M10130215USG294M10130529USG294M11130608USG294M10130718USG294M10130829USG294M10120321SG2026M10120605SG2026M10111114SH0825M10110330SH0935M10110401SH0935M10120123SH0935M10120313SH0935M10120404SH0935M10120802SH0935M10120919SH0935M10121121SH0935M10110302SH0729M10110503SH0729M10110701SH0729M10110809SH0729M10110817SH0729M10110825SH0729M10110913SH0729M10110923SH0729M10111116SH0729M20111123SH0729M10111201SH0729M10120120SH0729M10120130SH0729M10120210SH0729M10120217SH0729M10120301SH0729M10120412SH0729M10120507SH0729M10120525SH0729M20120530SH0729M10120703SH0729M10120724SH0729M10120803SH0729M10120810SH0729M10120827SH0729M10121025SH0729M10130102SH0729M10130212SH0729M10130213SH0729M10130314SH0729M10130418SH0729M10130517SH0729M10130603SH0729M10130606SH0729M10130617SH0729M10130701SH0729M10131014SH0729N10140430SH0729M10101206SH0035M10110624SH0035M10101206SH1391S10110307SH1391M10110302SH1391M10110701SH1391M10120404SH1391M10120705SH1391M10121010SH1391M10130118SH1391M10130125SH1391M10130515SH1391M10130626SH1391M10121206SH1604M10130308SH1604M10101127SH0495M10101217SH0495M10110131SH0495M10110512SH0495M10110817SH0495M10110901SH0495M10111008SH0495M20111221SH0495M10120217SH0495M10120224SH0495M10110527SH0495M10120727SH0495M10121004SH0495M10130102SH0495M10130213SH0495M10130301SH0495M10130812SH0495M10130924SH0495M10111201SH1015M10111208SH1015M10120217SH1015M10120425SH1015M10120618SH1015M10120713SH1015M10120823SH1015M10120827SH1015M10121022SH1015M10130212SH1015M10130213SH1015M10130828SH1015M10120831SH1385M10120918SH1385M10110412SH2144M10110706SH2144M10110923SH2144M10111008SH2144M10111205SH2144M20120103SH2144M10120210SH2144M10120713SH2144M10121121SH2144M10130325SH2144M10130529SH2144M10110302SH0761M10121129SH0761M10130719SH0761M10131001SH0761M20120322SH1276M10120525SH1276M10130503USG518M10130821USG518M10130828USG518M10131014USG518420194-10N10170714SH1182N10170817SH1182N10171019SH1182M10140303SH1570N10140805SH1570N10150702SH1570N10160311SH1570N10160421SH1570N10161206SH1570N10161223SH1570N10180227SG704M10131121SH0547N10140609SH0547M10140221SH0059M10140307SH0059N10140508SH0059N10140827SH0059N10150320SH0059N10160519SH0059N10160728SH0059N11160907SH0059N11161013SH0059N10161129SH0059N10170419SH0059N11170407SH0059N10170612SH0059N10170705

What the firm is doing

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)

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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