{
  "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-2594-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60NFPS30;    b)\t3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60NFPS35;   c)\t4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60NFPS40",
      "product_quantity": "36219 units",
      "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 15021312516685, Product Code/List Number/Item Code 60NFPS30, Lot Numbers:  3853441, 3868206, 3868207, 3871067, 3877651, 3887742, 3897854, 3904673, 3907995, 3926957, 3930007, 3939665, 3942472, 3946282, 3946283, 3955764, 3962605, 3982653, 3982654, 3988079, 4001201, 4008212, 4011376, 4018516, 4023788, 4029506, 4035731, 4048021, 4051634, 4053729, 4066288, 4077084, 4083942, 4092640, 4096832, 4105248, 4110445, 4122441, 4128014, 4138979, 4148025, 4159974, 4161993, 4168190, 4180503, 4185418, 4196272, 4209563, 4212773, 4218704, 4231493, 4233961, 4254232, 4276462, 4327915, 4334988, 4334989, 4345005, 4345006, 4351237, 4362840, 4369592, 4369593, 4374431, 4383622, 4389893, 4399165, 4400661;   b) UDI/DI 15021312516692, Product Code/List Number/Item Code 60NFPS35, Lot Numbers:  3853442, 3868200, 3871058, 3877653, 3884262, 3887743, 3894902, 3904675, 3911432, 3918014, 3926968, 3942534, 3946286, 3952348, 3955767, 3982655, 3988080, 3988081, 3988082, 3991146, 3991147, 3991148, 3991149, 4008213, 4008214, 4011377, 4015538, 4026689, 4033719, 4041969, 4051659, 4051660, 4053738, 4060203, 4063180, 4071966, 4083934, 4083935, 4092635, 4097816, 4107610, 4119111, 4138997, 4151030, 4153610, 4159953, 4168147, 4173732, 4195805, 4196273, 4204815, 4206814, 4212774, 4217441, 4223727, 4231494, 4237379, 4240144, 4260066, 4276463, 4286800, 4327936, 4327937, 4331602, 4331604, 4334990, 4335052, 4351238, 4352783, 4353063, 4353086, 4374432, 4381013, 4381014, 4381015, 4383623, 4388158, 4388159, 4389894, 4399167, 4400664;   c) UDI/DI 15021312516708; Product Code/List Number/Item Code 60NFPS40, Lot Numbers:  3853443, 3853444, 3868233, 3874303, 3887749, 3901298, 3907991, 3920946, 3933475, 3939636, 3949020, 3962567, 3982657, 3988089, 3988092, 3991150, 3991151, 4005639, 4008215, 4026668, 4053699, 4060217, 4083917, 4091394, 4110446, 4125819, 4145717, 4153576, 4161981, 4173733, 4196274, 4197613, 4204816, 4209564, 4217442, 4221341, 4231495, 4240145, 4254240, 4260067, 4276464, 4286801, 4327940, 4347202, 4362842, 4365799, 4388161, 4389895, 4395782, 4399168,",
      "more_code_info": ""
    }
  ]
}