{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "188990",
      "product_res_number": "Z-2587-2021",
      "event_date_initiated": "2021-09-09",
      "event_date_created": "2021-09-30",
      "recall_status": "Completed",
      "res_event_number": "88558",
      "product_code": "MRN",
      "product_description": "GENOSYL DS (Delivery System) console, for use as a vasodilator.",
      "code_info": "Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)",
      "firm_fei_number": "3014617112",
      "recalling_firm": "Vero Biotech, LLC",
      "address_1": "387 Technology Cir Nw Ste 125 387 Technology Cir Nw",
      "address_2": "Ste 125",
      "city": "Atlanta",
      "state": "GA",
      "postal_code": "30313-2411",
      "additional_info_contact": "908-388-3980",
      "reason_for_recall": "Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).",
      "root_cause_description": "Process control",
      "action": "On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, \"URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT.\"  The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced.",
      "product_quantity": "120 consoles (3 consoles affected)",
      "distribution_pattern": "Distributed within US to Texas and Illinois.",
      "openfda": {
        "k_number": [
          "K093260",
          "K092545",
          "K193481",
          "K000186",
          "K143213",
          "K212409",
          "K110344",
          "DEN000001",
          "K231823",
          "K081691",
          "K080484",
          "K070867",
          "K033779",
          "K171696",
          "K000653",
          "K242374",
          "K121021",
          "K120216",
          "K113272",
          "K233251",
          "K061901",
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          "K211153",
          "K200389",
          "K201339",
          "K093922",
          "K222930",
          "K131686",
          "K220898"
        ],
        "device_name": "Apparatus, Nitric Oxide Delivery",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5165",
        "device_class": "2",
        "registration_number": [
          "3006897516",
          "3004531588",
          "3012160128",
          "3012796317",
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          "3011193444",
          "2518435",
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}