{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Sunnyvale",
      "address_1": "1266 Kifer Rd Bldg 100",
      "reason_for_recall": "An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a  Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend",
      "address_2": "",
      "product_quantity": "2065 total",
      "code_info": "All",
      "center_classification_date": "20160805",
      "distribution_pattern": "US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.",
      "state": "CA",
      "product_description": "STAPLER 45, IS4000, model number 470298    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection  and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).",
      "report_date": "20160817",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Intuitive Surgical, Inc.",
      "recall_number": "Z-2348-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74705",
      "termination_date": "20170103",
      "more_code_info": "",
      "recall_initiation_date": "20160714",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}