{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "122221",
      "product_res_number": "Z-0084-2014",
      "event_date_initiated": "2013-09-16",
      "event_date_posted": "2013-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-07-09",
      "res_event_number": "66379",
      "product_code": "FCX",
      "k_numbers": [
        "K850020"
      ],
      "product_description": "PENTAX Endoscopic Accessories.  OF-B194.  Made in Japan.\r\n\r\nPENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.",
      "code_info": "Model OF-B194",
      "firm_fei_number": "1000080301",
      "recalling_firm": "Pentax Medical Company",
      "address_1": "3 Paragon Dr",
      "city": "Montvale",
      "state": "NJ",
      "postal_code": "07645-1782",
      "additional_info_contact": "Mr. Paul Silva\n800-431-5880 Ext. 2064",
      "reason_for_recall": "PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve.  A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.",
      "root_cause_description": "Use error",
      "action": "PENTAX Medical sent an \"Urgent Device Recall\" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. .   The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall.  The customer was instructed to identify and notify their customers if they further distributed the product.  \r\nThe notification instructs users to return the OF-B194 Valves for replacement with corrected product.  Customers were asked to complete the attached response form and fax back to Pentax Medical at 1.201.799.4063.  An enclosed UPS Airway Bill is to be used to return recalled product.  A contact phone number and email address is provided if the customer has questions (1.800.431.5880 xt2064).\r\nFor questions regarding this recall call 800-431-5880.\r\nPentax issued a press release on 10/31/2013.\r\nPentax posted their press release on their website at www.pentax.com.",
      "product_quantity": "76 units",
      "distribution_pattern": "Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.",
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        "device_name": "Insufflator, Automatic Carbon-Dioxide For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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