{
  "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-1102-2018",
      "product_description": "Re-Entry\" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446     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": "2224",
      "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: 3/27/2018  9/25/2021; Batch: 16852983 18912864 20404111  16969146 18932466 20458384  16987703 19157072 20491745  17078511 19318043 20517724  17159358 19338399 20567074  17248134 19596298 20567075  17672818 19623064 20593962  17780452 19705478 20658862  17910342 19737920 20682997  17960225 19850692 20735792  17976830 19934631 20769252  18100917 20065714 20830243  18106456 20169834 20884298  18172896 20198263 20909294  18280357 20284828 21027051  18398908 20312727 21101918  18821698 20330766 21181528  18876334"
    }
  ]
}