{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72626",
      "recalling_firm": "Masimo Corporation",
      "address_1": "Forty Parker",
      "address_2": "N/A",
      "postal_code": "92618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to  Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.",
      "recall_number": "Z-0338-2016",
      "product_description": "rainbow Reusable Sensors.  RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201;  RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407;  RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696;  RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697.  rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.",
      "product_quantity": "3476 units total (3322 units in US)",
      "reason_for_recall": "These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.",
      "recall_initiation_date": "20151028",
      "center_classification_date": "20151125",
      "termination_date": "20160518",
      "report_date": "20151202",
      "code_info": "2201  2407  2696  2697"
    }
  ]
}