{
  "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": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87445",
      "recalling_firm": "CAIRE DIAGNOSTICS INC",
      "address_1": "7020 Koll Center Pkwy",
      "address_2": "N/A",
      "postal_code": "94566-3103",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.",
      "recall_number": "Z-1284-2021",
      "product_description": "CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.",
      "product_quantity": "381 units (171 units U.S. and 210 units O.U.S.)",
      "reason_for_recall": "Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease.  Two issues affecting the FeNO readings:  1) Drift in the calibration gases and 2) Software error.  Each of these issues can cause FeNO scores/results to be erroneously high.",
      "recall_initiation_date": "20210226",
      "center_classification_date": "20210319",
      "termination_date": "20230324",
      "report_date": "20210331",
      "code_info": "All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).",
      "more_code_info": ""
    }
  ]
}