{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sittingbourne",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97517",
      "recalling_firm": "NOXBOX LTD",
      "address_1": "Unit 1",
      "address_2": "Eurolink Gateway; Castle Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Domestic: TN",
      "recall_number": "Z-0028-2026",
      "product_description": "NOxBOXi Nitric Oxide Delivery System;  Model Numbers: NOXBOX-I",
      "product_quantity": "1667 units",
      "reason_for_recall": "Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).",
      "recall_initiation_date": "20250909",
      "center_classification_date": "20251006",
      "report_date": "20251015",
      "code_info": "Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.",
      "more_code_info": ""
    }
  ]
}