{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215947",
      "product_res_number": "Z-0072-2026",
      "event_date_initiated": "2025-08-25",
      "event_date_posted": "2025-10-08",
      "recall_status": "Open, Classified",
      "res_event_number": "97567",
      "product_code": "LXA",
      "product_description": "Artegraft Collagen Vascular Graft.  Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M.  \n\n The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.",
      "code_info": "Model/Catalog/Part Number, UDI-DI (lot Numbers): \n\n1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016).\n\n2. AG636M, 00316837000022 (24H380-009).\n\n3. AG730M, 00316837000060 (24H380-014, 24H380-004).\n\n4. AG740M, 00316837000084 (24H380-003, 24H380-002).\n\n5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). \n\nExpiration date: 28 Jul 2027.",
      "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\n732-422-8333",
      "reason_for_recall": "Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.",
      "root_cause_description": "Process control",
      "action": "LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return.  If the product has been implanted, graft explantation/patient intervention is not required.  Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form.  Distributors were requested to indicate that they have quarantine affected units in stock and notified all customers who have received the product.",
      "product_quantity": "10 units",
      "distribution_pattern": "No US distribution. International distribution to Great Britian and Switzerland.",
      "openfda": {
        "device_name": "Tissue Graft Of 6mm And Greater",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P780002",
          "N16837",
          "P800058",
          "P020049"
        ],
        "registration_number": [
          "2219920",
          "2247686"
        ],
        "fei_number": [
          "2219920",
          "1000121696"
        ]
      }
    }
  ]
}