{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84375",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.",
      "recall_number": "Z-0667-2020",
      "product_description": "Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.",
      "product_quantity": "139",
      "reason_for_recall": "During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the  introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.",
      "recall_initiation_date": "20191118",
      "center_classification_date": "20191211",
      "termination_date": "20200625",
      "report_date": "20191218",
      "code_info": "Material Number/UPN: 6500  GTIN: 5060271140725  Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-2021), 17-C07 (Expiration: 19-Feb-2021), 17-C08 (Expiration: 20-Feb-2021)",
      "more_code_info": ""
    }
  ]
}