{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97420",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "address_2": "N/A",
      "postal_code": "84095-2416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of  Canada and Korea",
      "recall_number": "Z-2553-2025",
      "product_description": "10Fore Hemostasis Valve  Catalog Number / UDI-DI code:  MAPTEN4 / 00884450821305  MAPTEN42 / 00884450832509  MAPTEN452 / 00884450821329    The 10Fore Hemostasis Valve is intended to maintain hemostasis during the  introduction/withdrawal and use of diagnostic and interventional devices.",
      "product_quantity": "447",
      "reason_for_recall": "Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.",
      "recall_initiation_date": "20250725",
      "center_classification_date": "20250911",
      "report_date": "20250917",
      "code_info": "Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901  MAPTEN42 / 00884450832509 Lot Numbers: H3076189 H3111156 H3152504 H3155614 H3173674  MAPTEN452 / 00884450821329 Lot Number: H3111162"
    }
  ]
}