{
  "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": "2026-04-01",
    "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": "87763",
      "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 distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.",
      "recall_number": "Z-1682-2021",
      "product_description": "Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.",
      "product_quantity": "108 units",
      "reason_for_recall": "IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient.  Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result  in aspiration",
      "recall_initiation_date": "20210421",
      "center_classification_date": "20210525",
      "termination_date": "20240205",
      "report_date": "20210602",
      "code_info": "All units"
    }
  ]
}