{
  "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": [
    {
      "status": "Terminated",
      "city": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66379",
      "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": "Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.",
      "recall_number": "Z-0084-2014",
      "product_description": "PENTAX Endoscopic Accessories.  OF-B194.  Made in Japan.    PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.",
      "product_quantity": "76 units",
      "reason_for_recall": "PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve.  A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.",
      "recall_initiation_date": "20130916",
      "center_classification_date": "20131028",
      "termination_date": "20140709",
      "report_date": "20131106",
      "code_info": "Model OF-B194"
    }
  ]
}