{
  "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-2608-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tNEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25;   b)\tNEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30;   c)\tNEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35;   d)\tNEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40",
      "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 10351688518736, Product Code/List Number/Item Code 67NFP25, Serial Numbers:  3936586, 4033699, 4091401, 4334881;  b)  UDI/DI 10351688518743, Product Code/List Number/Item Code 67NFP30, Serial Numbers:  3853379, 3864236, 3874314, 3884252, 3901302, 3930043, 3955792, 3962588, 3997790, 4011356, 4033700, 4063161, 4097823, 4116100, 4145705, 4163839, 4331551, 4334882, 4374402, 4380994;  c)  UDI/DI 10351688518750, Product Code/List Number/Item Code 67NFP35, Serial Numbers:  3853380, 3874302, 3891535, 3923730, 3939680, 3952399, 3959334, 4001123, 4021415, 4086018, 4110430, 4130984, 4151052, 4176229, 4218691, 4237346, 4331592, 4333982, 4357246, 4383594, 4388098, 4395737;  d)  UDI/DI 10351688518767Product Code/List Number/Item Code 67NFP40, Serial Numbers:  3853381, 3861138, 3894884, 3923727, 3952393, 3987930, 4033701, 4083924, 4122439, 4156634, 4237348, 4334883, 4388099",
      "more_code_info": ""
    }
  ]
}