{
  "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": "2026-08-20",
    "results": {
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      "cfres_id": "67186",
      "product_res_number": "Z-0905-2008",
      "event_date_initiated": "2007-11-30",
      "event_date_posted": "2008-04-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-10-22",
      "res_event_number": "46330",
      "product_code": "EZN",
      "k_numbers": [
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      "product_description": "Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760",
      "code_info": "Lot numbers: W03-1606, W03-1649\n\n W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283",
      "firm_fei_number": "3001451463",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "500 Commander Shea Blvd",
      "city": "Quincy",
      "state": "MA",
      "postal_code": "02171-1518",
      "additional_info_contact": "Robert T. Miragliuolo\n508-683-4186",
      "reason_for_recall": "Sheath Removal Difficulty: Users experience difficulty in removing the sheath.",
      "root_cause_description": "Device Design",
      "action": "Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007.  The letter instructed users to check their inventory, remove any affected product and place them in quarantine.  It also included instructions for returning the product.  Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.",
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        "medical_specialty_description": "Gastroenterology, Urology",
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