{
  "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-1101-2018",
      "product_description": "Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278     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": "1716",
      "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 - 10/4/2021; Batch: 16682347 18705536 20623819  16893775 18773341 20658861  16943409 18876327 20685659  17003572 18898595 20735791  17017122 18987890 20798226  17075064 19058167 20830240  17184857 19515680 20884480  17192710 19900108 20909296  17603504 20094213 20942365  17703884 20261038 21055683  17797369 20312726 21129580  17990644 20401204 21157953  18084498 20458382 21179391  18095911 20491743 21218849  18691891 20517726"
    }
  ]
}