{
  "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": "Auckland",
      "state": "",
      "country": "New Zealand",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97591",
      "recalling_firm": "Fisher & Paykel Healthcare, Ltd.",
      "address_1": "15 Maurice Paykel Place",
      "address_2": "East Tamaki",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.",
      "recall_number": "Z-0158-2026",
      "product_description": "Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723",
      "product_quantity": "51,144",
      "reason_for_recall": "When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.",
      "recall_initiation_date": "20250918",
      "center_classification_date": "20251015",
      "report_date": "20251022",
      "code_info": "REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248.  Disinfection Kit User Manual all revisions before UI-185043723 rev P",
      "more_code_info": ""
    }
  ]
}