{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "49177",
      "product_res_number": "Z-0339-2007",
      "event_date_initiated": "2006-08-31",
      "event_date_posted": "2007-01-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-04",
      "res_event_number": "36693",
      "product_code": "JOH",
      "k_numbers": [
        "K913859"
      ],
      "product_description": "Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.",
      "code_info": "Lots 1008187, 1023402 and 1012767.",
      "firm_fei_number": "1824231",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "5700 W 23rd Ave",
      "city": "Gary",
      "state": "IN",
      "postal_code": "46406-2617",
      "additional_info_contact": "800-858-7670 Ext. 5566",
      "reason_for_recall": "Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.",
      "root_cause_description": "Other",
      "action": "Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm.  Distributors were asked to notify their customers of the recall.",
      "product_quantity": "197",
      "distribution_pattern": "Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.",
      "openfda": {
        "device_name": "Tube Tracheostomy And Tube Cuff",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5800",
        "device_class": "2",
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