{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "150058",
      "product_res_number": "Z-0318-2017",
      "event_date_initiated": "2016-08-15",
      "event_date_posted": "2016-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-23",
      "res_event_number": "75332",
      "product_code": "FDS",
      "k_numbers": [
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      "product_description": "Pentax Video Gastroscope 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 upper digestive tract including the esophagus, stomach and duodenum.",
      "code_info": "EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK",
      "firm_fei_number": "1000080301",
      "recalling_firm": "Pentax of America Inc",
      "address_1": "3 Paragon Dr",
      "city": "Montvale",
      "state": "NJ",
      "postal_code": "07645-1782",
      "additional_info_contact": "Mr. Paul Silva\n973-628-2199",
      "reason_for_recall": "PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.",
      "root_cause_description": "Labeling Change Control",
      "action": "Pentax sent as \"Urgent Field Correction\" and Field Correction Response Form dated August 15, 2016 to their affected customers.",
      "product_quantity": "3,436 (US) and 14,488 (OUS)",
      "distribution_pattern": "US Nationwide and Japan",
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