{
  "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,
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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": "50 units",
      "code_info": "Model #'s FCP-8P and FCP-9P",
      "center_classification_date": "20160628",
      "distribution_pattern": "Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam",
      "state": "NJ",
      "product_description": "Choledochoscope  Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct 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-2067-2016",
      "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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}