{
  "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": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82817",
      "recalling_firm": "Xhale Assurance, Inc.",
      "address_1": "3630 Sw 47th Ave Ste 100",
      "address_2": "N/A",
      "postal_code": "32608-7555",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution to AZ, CA, FL, KS, LA, MA , MO, MS, NC, NY, OH, PA, TX, WI.      International distribution to Canada, Germany, Malaysia, United Kingdom.",
      "recall_number": "Z-2133-2019",
      "product_description": "Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only    Product Usage:  The Assurance¿ Nasal Alar SpO2  Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision",
      "product_quantity": "701,272 devices total",
      "reason_for_recall": "These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.",
      "recall_initiation_date": "20190508",
      "center_classification_date": "20190730",
      "termination_date": "20220425",
      "report_date": "20190807",
      "code_info": "Reference Codes (Lot Numbers): 0303 (101619, 101624, 101628, 101632, 101637, 101642, 101646, 101647, 101651, 101701, 201651, 101707, 101715, XH101711, XH101720, XH101715, XH101726, XH101729, XH101733, XH101737, XH101820, XH101842), 301-11214 (TR101711, TR101715, TR101720, TR101726, TR101729, TR101744, TR101733, TR101737, TR101748, TR101742, TR101746, TR101750, TR101803, TR101811, TR101817, TR101820, TR101824, TR101829, TR101833, TR101838, TR101842, TR101847, TR101852), 0201-A01(PF101736, PF101806, PF101814, PF101817, PF101819, PF101822, PF101828, PF101833, PF101838).  Instructions for Use for revisions 10412_7 and prior (i.e. 10412_6, 10412_5, etc) as well as 10358_6 and prior.    Shelf life is 3 years for sensors manufactured prior to Oct 2018.  5 years for sensor manufactured on or after Oct 2018."
    }
  ]
}