{
  "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": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97661",
      "recalling_firm": "BALT USA, LLC",
      "address_1": "29 Parker Ste 100",
      "address_2": "N/A",
      "postal_code": "92618-1667",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.",
      "recall_number": "Z-0188-2026",
      "product_description": "Brand Name: MEGA Ballast Distal Access Platform  Product Name: Mega Ballast  Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110  Software Version: N/A  Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only.  Component: Not a component",
      "product_quantity": "207 catheters",
      "reason_for_recall": "Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.",
      "recall_initiation_date": "20250925",
      "center_classification_date": "20251024",
      "report_date": "20251105",
      "code_info": "Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810)   Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956"
    }
  ]
}