{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ashland",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "58185",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "28 Howe St",
      "address_2": "N/A",
      "postal_code": "01721-1305",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "recall_number": "Z-0157-2015",
      "product_description": "Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852      Item Number: 16110    Product Usage:  This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity",
      "product_quantity": "165 units",
      "reason_for_recall": "Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line",
      "recall_initiation_date": "20110301",
      "center_classification_date": "20141031",
      "termination_date": "20141106",
      "report_date": "20141112",
      "code_info": "Lot Numbers:  ML13,  MM04.    Manufacturing datese September 13, 2010 through October 4, 20 I 0."
    }
  ]
}