{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Allston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98493",
      "recalling_firm": "SUMMA THERAPEUTICS, LLC",
      "address_1": "119 Braintree St Ste 508",
      "address_2": "",
      "postal_code": "02134-1851",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of New Jersey, Florida.",
      "recall_number": "Z-1704-2026",
      "product_description": "Brand Name: Finesse BTK Multicath  Product Name: Injectable Angioplasty Balloon Catheter  Model/Catalog Number: FS252251502  Product Description: 5 French sheath, 0.014\" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm  Component: NA",
      "product_quantity": "22 units",
      "reason_for_recall": "Potential for the balloon in the device to not meet burst specifications.",
      "recall_initiation_date": "20250721",
      "center_classification_date": "20260330",
      "report_date": "20260408",
      "code_info": "Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;",
      "more_code_info": ""
    }
  ]
}