{
  "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": "Burlington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80627",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "63 2nd Ave",
      "address_2": "N/A",
      "postal_code": "01803-4413",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to accounts in FL, NV, OK, SC, and TX.",
      "recall_number": "Z-3042-2018",
      "product_description": "AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.",
      "product_quantity": "N/A",
      "reason_for_recall": "The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.",
      "recall_initiation_date": "20180619",
      "center_classification_date": "20180913",
      "termination_date": "20190417",
      "report_date": "20180919",
      "code_info": "AGC2134"
    }
  ]
}