{
  "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,
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  "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-1104-2018",
      "product_description": "Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757     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": "3762",
      "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: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005  16632804 18000051 19156402  16668232 18071028 19272679  16687725 18187908 19323232  16701905 18238926 19338380  16725748 18312539 19374391  16746021 18347202 19419431  16768170 18403711 19510783  16769687 18453529 19543444  16791047 18467224 19596296  16813326 18511816 19622910  16861185 18522401 19652445  16886796 18631119 19672586  16911889 18702248 19824542  16918770 18702249 19884752  16931022 18705836 20001153  16931071 18780195 20091268  16964525 18800088 20118753  17143046 18818625 20198261  17227380 18820391 20288613  17399143 18900337 20321757  17446684 18900338 20477761  17604237 18955686 20753764  17659535 18977772 20789373  17670349 19006930 21009191  17710577 19087159 21046808  17766030 19097822 21316321  17826778"
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