{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94852",
      "recalling_firm": "Smiths Medical ASD Inc.",
      "address_1": "6000 Nathan Ln N",
      "address_2": "",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-2603-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tNEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025;   b)\tNEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030;   c)\tNEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035;   d)\tNEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040",
      "product_quantity": "",
      "reason_for_recall": "Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.",
      "recall_initiation_date": "20240529",
      "center_classification_date": "20240823",
      "report_date": "20240904",
      "code_info": "a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers:   3949029, 4138994, 4171564, 4334857, 4383590;  b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers:  3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373;  c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers:  3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861;  UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers:  3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376",
      "more_code_info": ""
    }
  ]
}