{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70604",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "N/A",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of:  Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland,  Austria, Hungary, Netherlands and Portugal.",
      "recall_number": "Z-1355-2015",
      "product_description": "Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits",
      "product_quantity": "289",
      "reason_for_recall": "Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.",
      "recall_initiation_date": "20150225",
      "center_classification_date": "20150331",
      "termination_date": "20170630",
      "report_date": "20150408",
      "code_info": "UPN #                               LOT #  H7493933108200 17245003, 17416605, 17489192  H7493933108350 17245004, 17245005, 17370709, 17408756  H749393310835K1 17411333, 17493554  H7493933110200 17318047  H7493933110350 17275822, 17438003, 17494025, 17501572  H749393311035K1 17328808, 17403871, 17416578, 17459144  H7493933110400 17275824, 17416608  H7493933112350 17245006, 17259580, 17275819  H7493933114350 17275815, 17338207  with Expiration Dates between January 30, 2016 and May 8, 2016"
    }
  ]
}