{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Redwood City",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80180",
      "recalling_firm": "PENTAX of America Inc",
      "address_1": "303 Convention Way Ste 1",
      "address_2": "N/A",
      "postal_code": "94063-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution US nationwide.",
      "recall_number": "Z-2256-2018",
      "product_description": "C2 CryoBalloon Focal Catheter, REF FG-1009.  C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.",
      "product_quantity": "57 units",
      "reason_for_recall": "The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.",
      "recall_initiation_date": "20180330",
      "center_classification_date": "20180619",
      "termination_date": "20210428",
      "report_date": "20180627",
      "code_info": "Lot Codes: 02132018-01 & 02162018-03"
    }
  ]
}