{
  "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,
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  },
  "results": [
    {
      "status": "Terminated",
      "city": "Jeffersonville",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89882",
      "recalling_firm": "Freudenberg Medical, Llc",
      "address_1": "2301 Centennial Blvd",
      "address_2": "",
      "postal_code": "47130-8975",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US distribution: GA, OH  Foreign distribution: Netherlands",
      "recall_number": "Z-1017-2022",
      "product_description": "Empower Introducer Sheath with Hydrophilic Coating  21F x 56cm  Model: 668782-200 (OUS)",
      "product_quantity": "8 units (OUS)",
      "reason_for_recall": "Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to  peripheral ischemia",
      "recall_initiation_date": "20220221",
      "center_classification_date": "20220428",
      "termination_date": "20240418",
      "report_date": "20220504",
      "code_info": "Lot Numbers:  PD02, PD00013142  UDI: 00802526618000",
      "more_code_info": ""
    }
  ]
}