{
  "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": [
    {
      "country": "United States",
      "city": "Rancho Santa Margarita",
      "address_1": "22872 Avenida Empresa",
      "reason_for_recall": "The product may not have met sterility requirements . Use of  a non-sterile device on a patient may expose the patient to infectious agents.",
      "address_2": "",
      "product_quantity": "2,016 units",
      "code_info": "Lot: 1330981, Exp: July 15, 2021  UDI: 0 0607915 12312 3",
      "center_classification_date": "20190711",
      "distribution_pattern": "Worldwide Distribution - US Nationwide Distribution:   OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland",
      "state": "CA",
      "product_description": "Kii Fios First Entry, 5 X 75 mm, RX only,  REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical  Resource Corp.    Product Usage:  Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.",
      "report_date": "20190717",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Applied Medical Resources Corp",
      "recall_number": "Z-1959-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "82986",
      "termination_date": "20200612",
      "more_code_info": "",
      "recall_initiation_date": "20190128",
      "postal_code": "92688-2650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}