{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93794",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International distribution to the country of Japan only.",
      "recall_number": "Z-1153-2024",
      "product_description": "EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.",
      "product_quantity": "0 US; 74 OUS",
      "reason_for_recall": "Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.",
      "recall_initiation_date": "20231219",
      "center_classification_date": "20240216",
      "report_date": "20240228",
      "code_info": "UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152;  UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573."
    }
  ]
}