{
  "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": "Covington",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72922",
      "recalling_firm": "C.R. Bard, Inc.",
      "address_1": "8195 Industrial Blvd NE",
      "address_2": "N/A",
      "postal_code": "30014-1497",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed US (nationwide) and the countries of Canada and Australia.",
      "recall_number": "Z-1358-2016",
      "product_description": "BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.",
      "product_quantity": "1,428,000 units (total)",
      "reason_for_recall": "Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.",
      "recall_initiation_date": "20151218",
      "center_classification_date": "20160408",
      "termination_date": "20160629",
      "report_date": "20160420",
      "code_info": "Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.",
      "more_code_info": ""
    }
  ]
}