{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Redwood City",
      "address_1": "303 Convention Way",
      "reason_for_recall": "Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.",
      "address_2": "Ste 1",
      "product_quantity": "4 devices",
      "code_info": "Lot/Serial number 08062018-03",
      "center_classification_date": "20190514",
      "distribution_pattern": "Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA.  There was no government/military distribution.  Foreign distribution was made to Canada, Germany, and the Netherlands.",
      "state": "CA",
      "product_description": "Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX.    Product Usage:  The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.",
      "report_date": "20190522",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "PENTAX of America Inc",
      "recall_number": "Z-1327-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "82274",
      "termination_date": "20200814",
      "more_code_info": "",
      "recall_initiation_date": "20181203",
      "postal_code": "94063-1465",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}