{
  "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": "Terminated",
      "city": "Mirandola",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88267",
      "recalling_firm": "QURA S.R.L.",
      "address_1": "Via Di Mezzo 23",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of South Carolina.",
      "recall_number": "Z-2277-2021",
      "product_description": "Spectrum Medical Quantum Standard heat exchanger",
      "product_quantity": "1088 units",
      "reason_for_recall": "Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.",
      "recall_initiation_date": "20210322",
      "center_classification_date": "20210812",
      "termination_date": "20240422",
      "report_date": "20210818",
      "code_info": "Batch Numbers:  B000129, C000415, C000416, C000417"
    }
  ]
}