{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139535",
      "product_res_number": "Z-0001-2016",
      "event_date_initiated": "2015-07-14",
      "event_date_posted": "2015-10-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-27",
      "res_event_number": "71987",
      "product_code": "FDI",
      "k_numbers": [
        "K140763"
      ],
      "product_description": "Histolock  Resection Device, US Endoscopy.  \nAn electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.",
      "code_info": "M/N: 00711117; Lot #: 1505956",
      "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": "Mrs. Kia (NMI) Pennington\n800-769-8226",
      "reason_for_recall": "The company has determined the sterility cannot be assured for the affected lot.",
      "root_cause_description": "Employee error",
      "action": "The firm, US Endoscopy, sent an \"URGENT: HISTOLOCK\" RESECTION DEVICE RECALL\" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records.\n\nIf you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com.",
      "product_quantity": "41 units",
      "distribution_pattern": "US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.",
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          "K220846",
          "K140726",
          "K083049",
          "K152580",
          "K901322",
          "K930022",
          "K923671",
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        ],
        "registration_number": [
          "1528319",
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        ],
        "device_name": "Snare, Flexible",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4300",
        "device_class": "2"
      }
    }
  ]
}