{
  "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": "Montvale",
      "address_1": "3 Paragon Dr",
      "reason_for_recall": "Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.",
      "address_2": "",
      "product_quantity": "819 units",
      "code_info": "Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX",
      "center_classification_date": "20160628",
      "distribution_pattern": "Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam",
      "state": "NJ",
      "product_description": "Ultrasound Gastroscope  Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric",
      "report_date": "20160706",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Pentax Medical Company",
      "recall_number": "Z-2077-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73894",
      "termination_date": "20171221",
      "more_code_info": "",
      "recall_initiation_date": "20160406",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}