{
  "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": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "36454",
      "product_res_number": "Z-0498-05",
      "event_date_initiated": "2004-12-20",
      "event_date_posted": "2005-02-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-12-02",
      "res_event_number": "30721",
      "product_code": "MIH",
      "pma_numbers": [
        "P020018"
      ],
      "product_description": "Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-82.",
      "code_info": "All units distributed on or before 12/17/04.",
      "firm_fei_number": "1820334",
      "recalling_firm": "Cook, Inc.",
      "address_1": "750 Daniels Way",
      "city": "Bloomington",
      "state": "IN",
      "postal_code": "47404-9120",
      "additional_info_contact": "Customer Relations\n800-457-4500",
      "reason_for_recall": "The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.",
      "root_cause_description": "Other",
      "action": "Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.",
      "distribution_pattern": "Nationwide and Canada.",
      "openfda": {
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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