{
  "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,
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  "results": [
    {
      "cfres_id": "218150",
      "product_res_number": "Z-1312-2026",
      "event_date_initiated": "2025-12-24",
      "event_date_posted": "2026-02-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98285",
      "product_code": "OFR",
      "product_description": "Medline 14 Fr Suction Catheter Kits\nSKU DYND40972 - respiratory convenience kit",
      "code_info": "Kit lot 48625040001\nUDI (ea) 10080196033317\nUDI (case) 40080196033318¿",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "reason_for_recall": "A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply.",
      "product_quantity": "141,971",
      "distribution_pattern": "Distribution US nationwide and Canada.",
      "openfda": {
        "registration_number": [
          "1643817",
          "3004950768",
          "3003898360",
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        ],
        "device_name": "Tracheobronchial Suction Catheter Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.6810",
        "device_class": "1"
      }
    }
  ]
}