{
  "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": [
    {
      "country": "United States",
      "city": "Montvale",
      "address_1": "3 Paragon Dr",
      "reason_for_recall": "Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.",
      "address_2": "",
      "product_quantity": "US: 118 units",
      "code_info": "Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411,   H110497, G110360, G110363, G110364, G110371, G110366, G110368,   G110372, H110434, H110447, G110380, H110455, G110298, H110445,   H110449, H110461, G110292, G110346, G110365, H110494, H110495,   H110474, G110376, G110319, G110328, H110473, H110413, H110414,  H110427, H110453, H110454, H110415, G110312, G110321, H110467,   H110471, H110412, G110289, G110303, G110294, H110420, G110299,   G110300, H110448, H110452, G110386, G110331, H110451, H110493,   G110313, G110314, H110464, H110496, H110433, G110373, G110375,   G110317, H110431, H110417, G110291, G110302, G110369, G110378,   G110335, G110387, G110390, G110392, G110395, G110311, G110327,   G110332, G110382, G110355, G110357, G110287, G110320, H110435,   H110481, H110485, H110486, G110354, G110316, G110318, G110362,   G110393, H110498, H110456, H110457, H110459, G110337, G110356,   H110421, H110429, G110290, G110352, H110470, H110478, G110383,   G110384, G110361.",
      "center_classification_date": "20170823",
      "distribution_pattern": "Nationwide",
      "state": "NJ",
      "product_description": "Ultrasound Video Gastroscope, Model EG-3670URK,     The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.",
      "report_date": "20170830",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Pentax of America Inc",
      "recall_number": "Z-3067-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77380",
      "termination_date": "20200521",
      "more_code_info": "",
      "recall_initiation_date": "20170523",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}