{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Burlington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92825",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "32 3rd Ave",
      "address_2": "N/A",
      "postal_code": "01803-4414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution to the countries of Belgium, France, Germany, and United Kingdom.",
      "recall_number": "Z-2468-2023",
      "product_description": "The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy.    The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)",
      "product_quantity": "225 units",
      "reason_for_recall": "Burrs (molding flash) on the cutter may tear the harvested vien",
      "recall_initiation_date": "20230713",
      "center_classification_date": "20230828",
      "report_date": "20230906",
      "code_info": "(1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840663110483  Lot Numbers: All lots starting with CHV. Only lots beginning with CHV are being recalled. Older lots (with CL lot prefixes) are not being recalled. REF (Catalog #) LOT Catalog Number:  (1)40025  Lot Number: CHV1003, CHV1006, CHV1022 (2) 40030  Lot Number:  CHV1002, CHV1004, (3) 40035  Lot Number: CHV1001, CHV1005"
    }
  ]
}