{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73985",
      "recalling_firm": "Pentax Medical Company",
      "address_1": "3 Paragon Dr",
      "address_2": "N/A",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-2279-2016",
      "product_description": "Ultrasound Gastroscope    Product Usage:  Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.",
      "product_quantity": "819 units",
      "reason_for_recall": "Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.",
      "recall_initiation_date": "20160406",
      "center_classification_date": "20160722",
      "termination_date": "20170717",
      "report_date": "20160803",
      "code_info": "Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK."
    }
  ]
}