{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216366",
      "product_res_number": "Z-0289-2026",
      "event_date_initiated": "2025-09-25",
      "event_date_posted": "2025-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97700",
      "product_code": "LXA",
      "product_description": "Artegraft Collagen Vascular Graft;\nREF: AG1015;",
      "code_info": "REF: AG1015;\nUDI-DI: 00316837000343;\nLot/Serial Number: 23MM581-016;",
      "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": "Timothy Rodenberger\n781-362-5449",
      "reason_for_recall": "The device was incorrectly packed in the wrong size labeled outer packaging.",
      "root_cause_description": "Packaging change control",
      "action": "On September 25, 2025, an \"URGENT: MEDICAL DEVICE RECALL\" letter was sent to the customer.\nActions to be taken: \nCheck your inventory against the list of lots in this letter. Immediately quarantine any\nrecalled devices. Complete and return the form provided even if you have no devices in inventory. If the product has been implanted, graft explantation/patient intervention is NOT required. Scan the reply form and send it to recalls@lemaitre.com. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided.\nIf you have transferred devices to another facility, please forward a copy of this recall\nletter to them.\n\nIf you have any questions, contact Sr. Director, Quality Affairs, via email: mnelson@lemaitre.com or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.",
      "product_quantity": "1 unit",
      "distribution_pattern": "US distribution to the state of: AR",
      "openfda": {
        "pma_number": [
          "P020049",
          "N16837",
          "P800058",
          "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"
      }
    }
  ]
}