BRANMOOR
THURSDAY · 14 MAY 2026

FDA Device Recall Z-2601-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

Lot / serial / GTIN: 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

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 record

Recall number
Z-2601-2024
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
Worldwide distribution.
Recall initiated
2024-05-29
Classified by FDA Center
2024-08-23
FDA published
2024-09-04
Recalling firm
Smiths Medical ASD Inc.
Firm location
Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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