{
  "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": "113109",
      "product_res_number": "Z-0008-2013",
      "event_date_initiated": "2012-09-06",
      "event_date_posted": "2012-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-10-22",
      "res_event_number": "63253",
      "product_code": "HGI",
      "product_description": "Sterile, single-use, disposable electrosurgical electrode holder.  It connects the electrode to the foot activated electric generator.  Label reads in part \"***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***\"\n\nGynex catalog number:  950 (Gynex REF 950, Electrode Handpiece)\n\nIt connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.",
      "code_info": "Manufacturer's lot number:  54-12-2-21-12.",
      "firm_fei_number": "3001238683",
      "recalling_firm": "Gynex Corporation",
      "address_1": "14603 NE 87th St.",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052",
      "additional_info_contact": "Karen L Cardiff\n425-882-1179",
      "reason_for_recall": "The wrong electrical connector pin was attached to the cord during assembly by the manufacturer.  this electrical connector is too big to fit into the port on the foot activated generator.  this makes the device unusable.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Consignees were first notified by phone with a follow up e-mail or fax.  The consignees were asked to complete the response section regarding the destruction/return of the device.\nFor questions regarding this recall call 425-882-1179.",
      "product_quantity": "19 boxes (containing 12 electorde hand pieces each)",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K925478",
          "K905263",
          "K130606",
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          "K913213",
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        "registration_number": [
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        "fei_number": [
          "3009903460",
          "3002750084",
          "3002770040",
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          "3011120183",
          "3015173212",
          "1000120768",
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          "3001319476",
          "3011989923",
          "3002806315",
          "2020550",
          "1000138054",
          "3005075853",
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          "3004636440",
          "3013557562",
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          "3001238683",
          "3003790304",
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          "1721676",
          "3006469671"
        ],
        "device_name": "Electrocautery, Gynecologic (And Accessories)",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4120",
        "device_class": "2"
      }
    }
  ]
}