{
  "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": "74880",
      "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": "Worldwide Distribution - \u0013 US Nationwide and in the countries of  Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.",
      "recall_number": "Z-2544-2016",
      "product_description": "1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile  REF# 1009-00J    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves",
      "product_quantity": "380 units",
      "reason_for_recall": "Wire which deploys the loop may be come detached at the handle causing the device to be inoperable",
      "recall_initiation_date": "20160803",
      "center_classification_date": "20160816",
      "termination_date": "20210408",
      "report_date": "20160824",
      "code_info": "Lot Number                     Exp Date  ELVH1078V¿                   2020-10  ELVH1079VA                 2020-10"
    }
  ]
}