{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "131574",
      "product_res_number": "Z-0861-2015",
      "event_date_initiated": "2014-10-31",
      "event_date_posted": "2014-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-06-01",
      "res_event_number": "69809",
      "product_code": "KOG",
      "k_numbers": [
        "K070420"
      ],
      "product_description": "UroSeal Adjustable Endoscopic Valve.  Model/Catalog # 00913410\nThe primary packaging is a Tyvek pouch.  The secondary package is a corrugate box.  5 units per box.\n\nUsed to cover the opening to the biopsy/suction channel of an endoscope.",
      "code_info": "Lot 1417696",
      "firm_fei_number": "1000122656",
      "recalling_firm": "US Endoscopy Group Inc",
      "address_1": "5976 Heisley Rd",
      "city": "Mentor",
      "state": "OH",
      "postal_code": "44060-1873",
      "additional_info_contact": "Kia Pennington\n800-769-8229",
      "reason_for_recall": "Packaging non-conformance related to the integrity of the sterile pouch seal.",
      "root_cause_description": "Equipment maintenance",
      "action": "Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter.  The letter identified the affected product and the reason for the recall.  Customers were asked to remove any affected product from their inventory and quarantine them.  Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at recall@usendoscopy.com as soon as possible.  The firm contacted customers regarding the RMA instructions and replacement product.  Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product.  Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.",
      "product_quantity": "100 units",
      "distribution_pattern": "Distributed to the states of FL, MO, OH and WI.",
      "openfda": {}
    }
  ]
}