{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Boulder",
      "address_1": "6797 Winchester Cir",
      "reason_for_recall": "Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device.  This issue could result delays or complications during surgical procedures.",
      "address_2": "",
      "product_quantity": "48 boxes",
      "code_info": "RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.",
      "center_classification_date": "20120706",
      "distribution_pattern": "Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.",
      "state": "CO",
      "product_description": "AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories.  AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series.    AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.",
      "report_date": "20120718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Encision, Inc.",
      "recall_number": "Z-1951-2012",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "61529",
      "termination_date": "20120807",
      "more_code_info": "",
      "recall_initiation_date": "20120615",
      "postal_code": "80301-3513",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}