{
  "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-2601-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60PFSS30;   b)\t3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60PFSS35;   c)\t4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE  , Product Code/List Number/Item Code 60PFSS40;   d)\t4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60PFSS45;   e)\t5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60PFSS50;   f)\t5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE  , Product Code/List Number/Item Code 60PFSS55",
      "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 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers:  3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678;  b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers:  3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627, 3939628, 3942452, 3942453, 3942454, 3946232, 3946233, 3946234, 3946235, 3946236, 3946237, 3946238, 3946239, 3946240, 3950393, 3955795, 3959329, 3959330, 3959331, 3959332, 3959333, 3982687, 3982688, 3982689, 3982690, 3988114, 3988115, 3988116, 3988117, 3988118, 3988119, 3988120, 3991184, 3991185, 3991186, 3997830, 3997831, 3997832, 4001205, 4005667, 4005668, 4008220, 4008221, 4011381, 4015560, 4015561, 4015563, 4018523, 4018525, 4026693, 4029513, 4033731, 4035749, 4035750, 4035751, 4035752, 4041967, 4041968, 4043935, 4048029, 4051627, 4051628, 4053721, 4053722, 4053723, 4053724, 4053725, 4060207, 4060208, 4063189, 4066281, 4066282, 4071978, 4071979, 4075237, 4075238, 4077091, 4080785, 4083909, 4083910, 4089298, 4092630, 4092631, 4093738, 4095922, 4097812, 4100877, 4100878, 4100879, 4100880, 4100881, 4107596, 4107597, 4110459, 4110460, 4113100, 4113101, 4119121, 4122430, 4125809, 4125810, 4128021, 4128022, 4130989, 4134022, 4136150, 4138980, 4142449, 4142450, 4145703, 4147998, 4147999, 4151032, 4153611, 4156608, 4159938, 4161966, 4161967, 4161969, 4163816, 4168154, 4171555, 4176218, 4179362, 4179363, 4179364, 4180490, 4185427, 4196282, 4196283, 4196284, 4197619, 4197620, 4197621, 4201386, 4204822, 4206824, 4206825, 4206826, 4209571, 4209572, 4209573, 4212784, 4216326, 4216327, 4216328, 4218711, 4221349, 4221350, 4223733, 4223734, 4226265, 4231507, 4231508, 4231509, 4233970, 4233971, 4237387, 4237388, 4237389, 4240155, 4240157, 4240158, 4240161, 4254256, 4254258, 4260071, 4267850, 4267851, 4267852, 4273429, 4273430, 4273431, 4273432, 4276468, 4276469, 4276470, 4276471, 4279337, 4279338, 4279339, 4283246, 4283247, 4283248, 4286806, 4286807, 4286808, 4289490, 4289491, 4292175, 4322679, 4322680, 4327896, 4327897, 4331616, 4331617, 4331618, 4331619, 4335029, 4335030, 4335031, 4335032, 4335033, 4335034, 4345022, 4345023, 4345024, 4345025, 4345026, 4351243, 4351245, 4352792, 4352793, 4360411, 4360412, 4360413, 4369605, 4369606, 4369607, 4369608, 4374455, 4374456, 4374457, 4381027, 4381028, 4381029, 4383638, 4383639, 4383640, 4383641, 4383642, 4388187, 4388188, 4388189, 4388190, 4389908, 4389909, 4393411, 4393415;  c) UDI/DI 15021312516784, Product Code/List Number/Item Code 60PFSS40, Lot Numbers:  3853472, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3871051, 3880704, 3884253, 3887750, 3887751, 3891514, 3891515, 3894870, 3894871, 3894872, 3894873, 3897870, 3897871, 3901299, 3901300, 3903699, 3917983, 3920944, 3920945, 3926959, 3939638, 3942475, 3942476, 3942477, 3942478, 3942479, 3942480, 3942481, 3946247, 3946248, 3946249, 3946250, 3946251, 3946252, 3959295, 3959296, 3959297, 3959298, 3982691, 3982692, 3982693, 3988121, 3988122, 3988123, 3988124, 3988125, 3988126, 3988127, 3991189, 3991190, 3991191, 3991192, 3991193, 3991194, 3997833, 4001208, 4001210, 4001211, 4005672, 4008222, 4008223, 4008224, 4011382, 4015564, 4015565, 4015567, 4015568, 4015569, 4033732, 4033733, 4035753, 4035754, 4040576, 4041970, 4041971, 4048014, 4051635, 4051636, 4053697, 4053698, 4056232, 4056233, 4060215, 4060216, 4063190, 4066283, 4066284, 4071982, 4071983, 4075239, 4075240, 4089303, 4092636, 4093739, 4097814, 4100884, 4100885, 4107612, 4107613, 4110461, 4113109, 4113110, 4116104, 4119086, 4119087, 4125820, 4128024, 4128025, 4130995, 4130996, 4134030, 4134031, 4136149, 4138993, 4142424, 4142425, 4145715, 4148003, 4148004, 4151054, 4153575, 4156631, 4159949, 4161979, 4163826, 4168165, 4168167, 4171556, 4176223, 4176224, 4179365, 4179366, 4180450, 4185428, 4196285, 4196286, 4196287, 4197622, 4197623, 4201387, 4201388, 4204823, 4206827, 4206828, 4206829, 4209574, 4209575, 4209576, 4209577, 4216329, 4216330, 4218712, 4221351, 4221352, 4223735, 4223736, 4226266, 4231510, 4231511, 4231512, 4233972, 4233973, 4233974, 4234637, 4234638, 4237390, 4237391, 4237392, 4240160, 4247293, 4254261, 4254262, 4260072, 4260073, 4267853, 4267854, 4267855, 4267856, 4273433, 4273434, 4273435, 4273436, 4276472, 4276473, 4276474, 4279340, 4279341, 4283249, 4286809, 4286810, 4286811, 4289492, 4289493, 4289494, 4292176, 4322681, 4322682, 4327900, 4327901, 4327934, 4331622, 4331623, 4335040, 4335041, 4335042, 4335043, 4335044, 4345028, 4345029, 4345030, 4345031, 4345032, 4345033, 4345034, 4348478, 4348479, 4348480, 4352797, 4352798, 4357238, 4357239, 4357240, 4357241, 4357242, 4357243, 4358509, 4365780, 4369609, 4369610, 4369611, 4374458, 4374459, 4374460, 4379946, 4379953, 4379954, 4381030, 4381031, 4383643, 4383644, 4383645, 4383646, 4388191, 4388192, 4388193, 4388194, 4389913, 4389914, 4389915, 4389916, 4389917, 4393418, 4393419, 4399203;  d) UDI/DI 15021312516791, Product Code/List Number/Item Code 60PFSS45, Lot Numbers:  3853473, 3853474, 3868198, 3868199, 3874305, 3880707, 3884261, 3894905, 3897859, 3904674, 3908003, 3918013, 3926960, 3930026, 3930027, 3939624, 3939669, 3942482, 3946291, 3946292, 3955775, 3955776, 3962573, 3982694, 3982695, 3988128, 3988129, 3991195, 3991196, 3991197, 3991198, 3991199, 4001213, 4001214, 4008225, 4008226, 4015570, 4015571, 4023790, 4033736, 4035755, 4040577, 4048026, 4051644, 4051645, 4056242, 4060218, 4060219, 4063191, 4066293, 4071974, 4083911, 4091393, 4093740, 4097836, 4105254, 4107585, 4110462, 4116091, 4122447, 4125825, 4128017, 4139001, 4145697, 4148015, 4151029, 4153609, 4159951, 4161965, 4176227, 4185429, 4196288, 4196289, 4197625, 4201390, 4206830, 4206831, 4209578, 4209579, 4212785, 4216331, 4217449, 4218713, 4226267, 4231513, 4231514, 4231515, 4233975, 4237393, 4240162, 4247294, 4254264, 4260074, 4267857, 4267858, 4273437, 4276475, 4276476, 4279342, 4279343, 4283250, 4283251, 4286812, 4292177, 4322683, 4335045, 4335046, 4335047, 4345035, 4347209, 4347210, 4351246, 4352794, 4353059, 4353060, 4355429, 4355430, 4374461, 4374462, 4374463, 4379948, 4379962, 4383647, 4383648, 4383649, 4388196, 4388197, 4388198, 4389918, 4393420, 4393421;  e) UDI/DI 15021312516807, Product Code/List Number/Item Code 60PFSS50, Lot Numbers:  3840057, 3868220, 3868221, 3868222, 3880714, 3884270, 3894907, 3897868, 3904679, 3911436, 3918023, 3920950, 3930029, 3930030, 3946241, 3946242, 3946243, 3949030, 3982696, 3991200, 3991201, 4008227, 4011383, 4015572, 4023791, 4026696, 4033737, 4035756, 4043934, 4051656, 4053710, 4071975, 4083923, 4086011, 4097837, 4110463, 4122454, 4128023, 4139014, 4145698, 4156619, 4161975, 4168152, 4176234, 4185430, 4196290, 4201391, 4206832, 4212786, 4218714, 4223737, 4231516, 4254266, 4267859, 4276477, 4279344, 4289495, 4322684, 4327905, 4335048, 4335049, 4345036, 4345038, 4351247, 4352795, 4365781, 4365782, 4365783, 4374464, 4383650, 4383651, 4389919, 4393422, 4393423;  f) UDI/DI 15021312516814, Product Code/List Number/Item Code 60PFSS55, Lot Numbers:  3868230, 3871032, 3880678, 3887732, 3894906, 3904653, 3911421, 3920954, 3923729, 3930009, 3930010, 3930011, 3946277, 3982697, 3997820, 4008228, 4015573, 4021424, 4026680, 4035757, 4051657, 4063192, 4077087, 4085995, 4091411, 4107589, 4116089, 4125802, 4128013, 4134015, 4142435, 4142436, 4151026, 4156661, 4161961, 4171558, 4180466, 4196291, 4201392, 4212787, 4231517, 4267860, 4279345, 4292178, 4322685, 4327891, 4327907, 4335050, 4345037, 4351248, 4352796, 4374465, 4383652, 4388199, 4388200, 4389920, 4399207, 4399209, 4400689",
      "more_code_info": ""
    }
  ]
}