{
  "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": "215833",
      "product_res_number": "Z-0034-2026",
      "event_date_initiated": "2025-09-02",
      "event_date_posted": "2025-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "97518",
      "product_code": "LXA",
      "product_description": "Artegraft Collagen Vascular Grafts\nModel Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;",
      "code_info": "Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;\nUDI-DIs: (1) 00316837000213, (2) 00316837000220, (3) 00316837000237, (4) 00316837000244, (5) 00316837000251, (6) 00316837000268, (7) 00316837000275, (8) 00316837000282, (9) 00316837000299, (10) 00316837000305, (11) 00316837000312, (12) 00316837000367, (13) 00316837000329, (14) 00316837000343, (15) 00316837000350;\nSerial Numbers: (1) 23DD203-019, 23DD203-046,      (2) 23DD203-024, 23DD203-029,     (3) 23DD203-045,     (4) 23DD203-018,    (5)  23DD203-004,     (6) 23DD203-021, 23DD203-044, 23DD203-038, 23DD203-039, 23DD203-011, 23DD203-032, 23DD203-031, 23DD203-043,      (7) 23DD203-040, 23DD203-030, 23DD203-037,     (8) 23DD203-035, 23DD203-033,      (9) 23DD203-034,     (10) 23DD203-036,      (11) 23DD203-022, 23DD203-023,      (12) 23DD203-017,      (13) 23DD203-027,      (14) 23KK498-014,      (15) 23DD203-026;",
      "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 bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On September 2, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. \nActions to be taken:\n1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices.\n2. Complete and return attached response form.\n3. If the product has been implanted, graft explantation/patient intervention is NOT required.\n4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided.\n5. 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.",
      "product_quantity": "28 units",
      "distribution_pattern": "US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.",
      "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"
      }
    }
  ]
}