{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96943",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,  ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,  FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,  LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,  MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,  NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,  Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,  Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,  Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,  Thailand, United Arab Emirates (UAE), United Kingdom.",
      "recall_number": "Z-2085-2025",
      "product_description": "Brand Name: FEM-FLEXII  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018AS  Software Version: N/A  Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
      "product_quantity": "558",
      "reason_for_recall": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.",
      "recall_initiation_date": "20250514",
      "center_classification_date": "20250710",
      "report_date": "20250716",
      "code_info": "Lot Code: Model No: FEMII018AS; UDI: 00690103168358; All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064",
      "more_code_info": ""
    }
  ]
}