{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97318",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "address_2": "N/A",
      "postal_code": "55112-5700",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution. US nationwide. International distribution worldwide.",
      "recall_number": "Z-2327-2025",
      "product_description": "RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696",
      "product_quantity": "247,702 US; 344,670 OUS",
      "reason_for_recall": "Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.",
      "recall_initiation_date": "20250724",
      "center_classification_date": "20250820",
      "report_date": "20250827",
      "code_info": "Model 0657 UDI-DI 00802526560934;  Model 0682 UDI-DI 00802526560958;  Model 0683 UDI-DI 00802526560965;  Model 0685 UDI-DI  00802526560972;  Model 0686 UDI-DI 00802526560989;  Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688;  Model 0693 UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701;  Model 0695 UDI-DI 00802526519093 00802526561016;  Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831"
    }
  ]
}