{
  "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": [
    {
      "status": "Ongoing",
      "city": "Caesarea",
      "state": "N/A",
      "country": "Israel",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92945",
      "recalling_firm": "Icecure Medical Ltd",
      "address_1": "7, Ha-Eshel",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2650-2023",
      "product_description": "IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures  Models:   (1)FAS3000000 (100-127 VAC);   (2)FAS3000000-2 (100-127 VAC)",
      "product_quantity": "16 units",
      "reason_for_recall": "Updated  User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)",
      "recall_initiation_date": "20190916",
      "center_classification_date": "20230929",
      "report_date": "20231011",
      "code_info": "UDI: (1)FAS3000000,  UDI:    07290015487160 (2)FAS3000000-2,  UDI: 07290015487290  All User Manual Revisions up to Rev.D."
    }
  ]
}