{
  "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,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "155847",
      "product_res_number": "Z-0073-2018",
      "event_date_initiated": "2017-05-24",
      "event_date_created": "2017-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-09",
      "res_event_number": "77367",
      "product_code": "FFK",
      "k_numbers": [
        "K914514"
      ],
      "product_description": "Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.",
      "code_info": "Model No. 9-195-371DS, Lot/Serial Number LDS12516",
      "firm_fei_number": "1450997",
      "recalling_firm": "Northgate Technologies, Inc.",
      "address_1": "1591 Scottsdale Ct",
      "city": "Elgin",
      "state": "IL",
      "postal_code": "60123-9361",
      "additional_info_contact": "800-348-0424",
      "reason_for_recall": "The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017.  Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.",
      "product_quantity": "186",
      "distribution_pattern": "US Distribution to the following states :  MA, NE and  TN  and Internationally  to Canada.",
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        "device_name": "Lithotriptor, Electro-Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4480",
        "device_class": "2"
      }
    }
  ]
}