{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80696",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 101",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of :  AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NB, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY and the countries of :  Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Martinique, Mexico, Monaco, Netherlands, Norway, Pakistan, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela",
      "recall_number": "Z-3024-2018",
      "product_description": "da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16    Product Usage:  EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories 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, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.",
      "product_quantity": "23,064 (S/Si)",
      "reason_for_recall": "Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.",
      "recall_initiation_date": "20180815",
      "center_classification_date": "20180912",
      "report_date": "20180919",
      "code_info": "Model Number 420179-16  Device Listing D088920  UDI Number 00886874111505  Lot Numbers:  N10170912  N10170928  N10170419  N10170927  N10170919  N10171009  N10170731  N10170529  N11170912  N11170909  N10170828  N10170922  N10161014  N10170522  N10170808  N10170904  N10171010  N10170920  N10170921  N10170804  N10170905  N11170905  N11170725  N10170918  N10170703  N10170911  N11170920  N10171004  N11170227  N10170908  N10170821  N10170801  N10170725  N10170822  N10170524  N10161019  N11160701  N10170705  N11170703  N11170705  N11170522  N11170605  N10170605  N10170516  N10170602  N11170419  N10170308  N11170308  N10170508  N10170303  N12170308  N10170418  N12170310  N10170412  N11170412  N12170412  N10170407  N10170502  N11170207  N10170321  N14170310  N11170202  N11170119  N11170303  N10161129  N13170310  N11170407  N11170214  N11170310  N10170310  N12170214  N10170213  N10170130  N10170202  N11161115  N10170207  N12170123  N10161018  N10170214  N11161014  N10161222  N11170213  N10170119  N11170123  N11161129  N11161212  N10170123  N10161208  N11160926  N11161021  N11170105  N12160707  N10170105  N10161212  N10161115  N11161025  N11161118  N10161118  N10161021  N11161122  N10161026  N10161122  N10161031  N10160701  N11161026  N10161025  N11160608  N10160708  N10160824  N11160629  N11161019  N10160926  N12160824  N11160913  N10160808  N11160808  N10160707  N10160913  N11160622  N13160824  N11160824  N10160608  N10160305  N10160524  N14160824  N11160705  N10160705  N10160714  N10160603  N11160511  N11160708  N10160217  N10160420  N10160429  N10160629  N11160425  N11150929  N10160511  N10160622  N11160429  N10160212  N10160322  N12150929  N10160614  N11160614  N11160603  N10160510  N11160309  N10160523  N11160129  N10160323  N10160328  N10150929  N10160202  N10160425  N10160413  N11160413  N10160406  N10160408  N10160316  N10160401  N10160309  N10160121  N10160129  N10160226  N10160229  N11160301  N10160227  N10160211  N11160202"
    }
  ]
}