{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218639",
      "product_res_number": "Z-1574-2026",
      "event_date_initiated": "2026-02-10",
      "event_date_posted": "2026-03-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98409",
      "product_code": "LXA",
      "product_description": "Artegraft Vascular Graft;\nREF#: AG740;",
      "code_info": "REF#: AG740;\nUDI-DI: 00316837000299;\nSerial Number: 24GG298-022;\nExpiration Date: 28Jun2027;",
      "firm_fei_number": "1000121696",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "206 N Center Dr",
      "city": "North Brunswick",
      "state": "NJ",
      "postal_code": "08902-4246",
      "additional_info_contact": "Laurie Churchill\n781-704-1855",
      "reason_for_recall": "Labeling mix-up resulting in the incorrect lot outer packaging of product.",
      "root_cause_description": "Labeling Change Control",
      "action": "On February 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken:\n1. Check your inventory against the list of lots in this letter. Immediately quarantine any\nrecalled devices.\n2. Complete the form at the end of this letter. Please note that you must return the form\neven if you have no devices in inventory.\n3. If the product has been implanted, graft explantation/patient intervention is NOT\nrequired.\n4. Scan the reply form and send it to recalls@lemaitre.com.\n5. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided.\n6. If you have transferred devices to another facility, please forward a copy of this recall letter to them.\nIf you have any questions, contact Monte Nelson; mnelson@lemaitre.com; 732-422-8333\nMonday through Friday, 8:00 AM to 4:30 PM, Eastern Time, or email Recalls@lemaitre.com",
      "product_quantity": "1 unit",
      "distribution_pattern": "US Nationwide distribution in the state of IL.",
      "openfda": {
        "pma_number": [
          "N16837",
          "P800058",
          "P020049",
          "P780002"
        ],
        "registration_number": [
          "2247686",
          "2219920"
        ],
        "fei_number": [
          "1000121696",
          "2219920"
        ],
        "device_name": "Tissue Graft Of 6mm And Greater",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}