{
  "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": "75306",
      "recalling_firm": "Pentax of America Inc",
      "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 and Japan",
      "recall_number": "Z-0636-2017",
      "product_description": "Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.",
      "product_quantity": "5,090 (US) and 14,209 (OUS)",
      "reason_for_recall": "Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).",
      "recall_initiation_date": "20160815",
      "center_classification_date": "20161119",
      "termination_date": "20180308",
      "report_date": "20161130",
      "code_info": "Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK"
    }
  ]
}