{
  "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": "Galway",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85649",
      "recalling_firm": "Medtronic Vascular Galway DBA Medtronic Ireland",
      "address_1": "Parkmore Business Park West",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution in TX, WI, CA, NY, AL, and MI.",
      "recall_number": "Z-2039-2020",
      "product_description": "Medtronic Confida Expandable Sheath, REF CES122230.  To provide a guide for catheters or devices introduced into the femoral iliac arteries.",
      "product_quantity": "103 units",
      "reason_for_recall": "Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)",
      "recall_initiation_date": "20200512",
      "center_classification_date": "20200527",
      "termination_date": "20220310",
      "report_date": "20200603",
      "code_info": "UDI:  00763000233815, All Lot Numbers"
    }
  ]
}