{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Road",
      "reason_for_recall": "Inaccurate readings.  Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.",
      "address_2": "",
      "product_quantity": "622 units",
      "code_info": "Catalog number: 101 and Serial Numbers: 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117,1124,1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347,  1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660, 1662-1664, 1666, 1667,1669-1679,1681-1684,1686,1689-1691, 1693-1710,1712-1715,1717-1750,1752-1757,1759-1771,1773-1785,1787,1788,1790-1809, 1811-1831,1833,1838,1839,1855-1858,1866, and TK001-TK011.",
      "center_classification_date": "20130212",
      "distribution_pattern": "Worldwide Distribution.",
      "state": "MI",
      "product_description": "Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.",
      "report_date": "20130220",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-0802-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "60695",
      "termination_date": "20131108",
      "more_code_info": "",
      "recall_initiation_date": "20101101",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}