{
  "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": "91792",
      "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": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland,  France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq, Israel, Italy,  Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia,  South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Unit. Arab Emir.",
      "recall_number": "Z-1397-2023",
      "product_description": "Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.  UPN: M00500070",
      "product_quantity": "6635 units US: 1815  US units;  4820 OUS units",
      "reason_for_recall": "Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the  potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's  Instructions for Use (\"IFU\").",
      "recall_initiation_date": "20230202",
      "center_classification_date": "20230418",
      "report_date": "20230426",
      "code_info": "GTIN: 8714729981909 All lots , All Expiration Dates"
    }
  ]
}