{
  "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": "2026-04-08",
    "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": "79424",
      "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": "E-Mail",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.",
      "recall_number": "Z-1100-2018",
      "product_description": "Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261     The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: \" Antegrade pyelography \" Pressure/perfusion study (Whitaker test) Therapeutic Indications: \" Nephrostomy catheter drainage \" Perfusion chemolysis of renal stones \" Percutaneous nephrolithotomy \" Percutaneous resection and coagulation of urothelial tumors",
      "product_quantity": "1480",
      "reason_for_recall": "Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.",
      "recall_initiation_date": "20171212",
      "center_classification_date": "20180318",
      "termination_date": "20191024",
      "report_date": "20180328",
      "code_info": "Expiration Date Range: 1/22/2018 - 10/24/2021; Batch: 16682515 18351959 19879547  16954904 18518065 20221526  17023624 18662849 20491742  17174677 18689958 20593965  17547901 18773158 20703428  17634224 18821699 20798225  17797370 18898592 20824604  17881031 19103570 20872724  17990643 19134817 20995561  18006579 19185066 21055681  18141765 19235546 21101919  18280356 19368679 21179390"
    }
  ]
}