{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216521",
      "product_res_number": "Z-0572-2026",
      "event_date_initiated": "2025-10-17",
      "event_date_posted": "2025-11-20",
      "recall_status": "Open, Classified",
      "res_event_number": "97757",
      "product_code": "LJE",
      "k_numbers": [
        "K132383"
      ],
      "product_description": "Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit\nProduct Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter\nModel/Catalog Number: BPCN0815K\nProduct Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length",
      "code_info": "Model: BPCN0815K;\nUDI: 00821925033016;\nLot Number: 25037006;",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Cynthia Ow\n484-896-5000",
      "reason_for_recall": "Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.",
      "root_cause_description": "Process control",
      "action": "On October 17, 2025, \"URGENT: MEDICAL DEVICE REMOVAL\" letters were sent to customers. Actions required: 1. 1. Examine your inventory and quarantine any affected devices. 2. Cease usage of the product with immediate effect. 3. Return any remaining affected product, please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of your affected product. 4. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA\n\nIf you require additional information, please do not hesitate to contact directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.",
      "product_quantity": "60 units",
      "distribution_pattern": "US Domestic: AK, CA, IA, KY, WA, WI;\n\nOUS International: Canada and Germany.",
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        ],
        "device_name": "Catheter, Nephrostomy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "registration_number": [
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