{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "221697",
      "product_res_number": "Z-2999-2026",
      "event_date_initiated": "2026-07-10",
      "event_date_posted": "2026-08-21",
      "recall_status": "Open, Classified",
      "res_event_number": "99506",
      "product_code": "OFR",
      "product_description": "Medline medical convenience kit labeled as:  TRACH TUBE KIT, Medline Kit SKU DYKM2330",
      "code_info": "UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Component labeling discrepancy",
      "root_cause_description": "Labeling Change Control",
      "action": "Medline Industries issued an URGENT MEDICAL DEVICE CORRECTION notice to its sole consignee on 7/10/2026 via USPS and email.  The notice explained the issue, potential risk, and attached the notice from Medtronic.  The notice from Medtronic provided the following information:  \n\"Customer Actions:\n\" Customers can continue to use the Covidien Shiley\" disposable decannulation plugs.\n\" Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue.\n\" Share this notice with all relevant personnel within your organization, and with any organization to which the affected product has been transferred or distributed.\"  Medline requested a response through their portal:  Website link: https://recalls.medline.com, \nRecall Reference #: R-26-115-FGX2.",
      "product_quantity": "45 kits",
      "distribution_pattern": "US Nationwide distribution in the state of California.",
      "openfda": {
        "registration_number": [
          "1643817",
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          "3004134948",
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        ],
        "device_name": "Tracheobronchial Suction Catheter Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.6810",
        "device_class": "1"
      }
    }
  ]
}