{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195568",
      "product_res_number": "Z-1745-2022",
      "event_date_initiated": "2022-06-23",
      "event_date_posted": "2022-09-13",
      "recall_status": "Open, Classified",
      "res_event_number": "90723",
      "product_code": "MRN",
      "k_numbers": [
        "K061901"
      ],
      "product_description": "INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user,\nModel Number:  10007",
      "code_info": "All serial numbers",
      "firm_fei_number": "3014074925",
      "recalling_firm": "Mallinckrodt, LLC.",
      "address_1": "1425 Us Highway 206",
      "city": "Bedminster",
      "state": "NJ",
      "postal_code": "07921-2653",
      "additional_info_contact": "Megan Vernak\n908-238-6600",
      "reason_for_recall": "The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Mallinkrodt issued via email on 6/23/22 an Urgent Field Safety Notice (FA-R-0023) stating reason for recall, health risk and action to take:\nUpon receipt of this Field Safety Notice (FSN), INOmax DSIR operators are advised not to use an upgraded Leoni Plus ventilator with the INOmax DSIR.\nThe INOmax DSIR Validated Ventilator List, supplied as Technical Bulletin TB-20005, will be revised to remove the Leoni Plus ventilator and distributed as soon as it is available.\n\nA response form is required for this FSN. Please complete the attached form and return as instructed.",
      "product_quantity": "4,225 units OUS",
      "distribution_pattern": "Foreign Only:\nArgentina\nAustralia\nAustria\nBeligum\nCanada\nChile\nColumbia\nCzech Republic\nDenmark\nEcuador\nEstonia\nFinland\nFrance\nGermany\nGreat Britain\nHungary\nIceland\nIreland\nItaly\nLatvia\nMexico\nNetherlands\nNorway\nPoland\nPortugal\nRomania\nSlovakia\nSouth Africa\nSpain\nSweden\nSwitzerland\nUAE\nUruguay",
      "openfda": {
        "k_number": [
          "K143213",
          "K130605",
          "K071516",
          "K212409",
          "K093260",
          "K201339",
          "K242578",
          "K211153",
          "K093922",
          "DEN000001",
          "K171696",
          "K033779",
          "K081691",
          "K233251",
          "K193481",
          "K061901",
          "K200389",
          "K080484",
          "K222930",
          "K120216",
          "K000653",
          "K000186",
          "K110344",
          "K110635",
          "K131686",
          "K231823",
          "K242374",
          "K113272",
          "K240410",
          "K092545",
          "K220898",
          "K121021",
          "K070867"
        ],
        "device_name": "Apparatus, Nitric Oxide Delivery",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5165",
        "device_class": "2",
        "registration_number": [
          "3014527933",
          "1625392",
          "2518435",
          "3019771924",
          "3012796317",
          "3011193444",
          "3006897516",
          "2133810",
          "3012160128",
          "9611296",
          "3004531588"
        ],
        "fei_number": [
          "3000203066",
          "2518435",
          "3019771924",
          "3012796317",
          "3014074925",
          "3011193444",
          "3006897516",
          "1000058335",
          "3012160128",
          "3004531588",
          "3002809568"
        ]
      }
    }
  ]
}