{
  "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,
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  "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": "126 units",
      "code_info": "Model #'s ECN-1530 and FCN-15X",
      "center_classification_date": "20160628",
      "distribution_pattern": "Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam",
      "state": "NJ",
      "product_description": "Choledocho-Nephroscope  Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.",
      "report_date": "20160706",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Pentax Medical Company",
      "recall_number": "Z-2066-2016",
      "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"
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}