Recall archive / FDA device enforcement

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List ... — FDA record Z-2602-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055
Reason: 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.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: Not supplied
Agency-reported status: Ongoing
Source record identifier: Z-2602-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056; b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers: 3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805; c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers: 3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930, d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers: 3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789; e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers: 3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 4327884, 4335084, 4345045, 4365784; f) UDI/DI 15021312000368, Product Code/List Number/Item Code 60SP030, Lot Numbers: , 3853491, 3853492, 3868316, 3877643, 3884256, 3894888, 3923735, 3952385, 3955780, 3965909, 3982711, 4001220, 4015600, 4021423, 4024939, 4051655, 4060225, 4077113, 4083929, 4086024, 4107575, 4116084, 4122451, 4131002, 4139003, 4142430, 4153593, 4161992, 4168181, 4171559, 4176237, 4185437, 4196300, 4204828, 4206846, 4209590, 4217452, 4221361, 4247296, 4254287, 4279350, 4283260, 4286823, 4335085, 4345046, 4369626, 4374484, 4382718, 4388214, 4389931, 4395806, 4400704; g) UDI/DI 15021312000375, Product Code/List Number/Item Code 60SP035, Lot Numbers: 3840044, 3853493, 3853494, 3868228, 3868229, 3884268, 3897848, 3907968, 3911420, 3926971, 3949027, 3952407, 3952408, 3955774, 3965910, 3982712, 3988164, 3988165, 3991210, 4005685, 4012662, 4018528, 4026679, 4034946, 4034947, 4056229, 4066278, 4077085, 4083940, 4085994, 4095919, 4107587, 4110471, 4119115, 4130987, 4139019, 4145700, 4151028, 4156660, 4161959, 4161960, 4176210, 4197629, 4206847, 4209591, 4212794, 4218724, 4226272, 4233983, 4240167, 4254288, 4260080, 4276485, 4283261, 4286824, 4289500, 4292185, 4322693, 4322695, 4335086, 4335087, 4335088, 4351253, 4352807, 4369623, 4369624, 4369625, 4382710, 4388215, 4389932, 4393428, 4393429; h) UDI/DI 15021312000382, Product Code/List Number/Item Code 60SP040, Lot Numbers: 3840061, 3853495, 3853496, 3861152, 3868210, 3868211, 3868212, 3894897, 3897846, 3907967, 3911423, 3930038, 3936574, 3946288, 3946289, 3946290, 3948791, 3949042, 3952338, 3952339, 3952340, 3955796, 3955797, 3982713, 3988166, 3991211, 3991212, 3997825, 4001221, 4015603, 4015605, 4015606, 4015608, 4026691, 4035769, 4041966, 4051661, 4056239, 4063194, 4070854, 4077066, 4083936, 4089288, 4092646, 4100889, 4107586, 4113097, 4119109, 4122427, 4130975, 4134011, 4142438, 4145678, 4151024, 4153604, 4159987, 4163838, 4171562, 4171563, 4176204, 4179372, 4185438, 4196301, 4201398, 4204829, 4206848, 4209592, 4212795, 4218725, 4221362, 4237399, 4240168, 4240169, 4254289, 4254290, 4273444, 4276486, 4283262, 4286825, 4289501, 4322696, 4322697, 4327952, 4335089, 4335090, 4348790, 4348791, 4351254, 4352806, 4353058, 4369629, 4369630, 4374485, 4374486, 4380061, 4383660, 4383661, 4388216, 4389933; i) UDI/DI 15021312000399, Product Code/List Number/Item Code 60SP045, Lot Numbers: 3840064, 3853497, 3868193, 3868194, 3868196, 3887754, 3894901, 3897885, 3911439, 3930048, 3942488, 3948793, 3952352, 3952353, 3952354, 3955808, 3959300, 3962575, 3982714, 3997826, 4001222, 4011387, 4015609, 4015610, 4035770, 4051647, 4056253, 4066297, 4077080, 4080782, 4089290, 4095915, 4105247, 4113116, 4119114, 4122452, 4130985, 4142432, 4145695, 4147994, 4153601, 4159988, 4161995, 4161996, 4168146, 4179373, 4185439, 4197630, 4201400, 4204830, 4209595, 4212796, 4216339, 4217453, 4221363, 4233984, 4233987, 4237400, 4254291, 4260081, 4276487, 4283263, 4286826, 4289502, 4335091, 4335092, 4345047, 4348793, 4348794, 4348795, 4348796, 4357227, 4357228, 4362881, 4362882, 4374487, 4381039, 4382711, 4383662, 4388217, 4388218, 4389934, 4393431, 4399221; j) UDI/DI 15021312000405, Product Code/List Number/Item Code 60SP050, Lot Numbers: 3840086, 3853498, 3868219, 3887748, 3897855, 3907970, 3942494, 3949034, 3952382, 3952383, 3962579, 3982715, 3988167, 3997827, 4001223, 4015611, 4015613, 4027992, 4027993, 4040760, 4053719, 4066285, 4089299, 4100886, 4113120, 4125829, 4134017, 4145722, 4147983, 4156662, 4163817, 4173738, 4179374, 4180461, 4196302, 4206849, 4209593, 4216340, 4218726, 4233986, 4254292, 4254293, 4273445, 4276488, 4279351, 4289503, 4322699, 4327950, 4335093, 4351255, 4352805, 4369627, 4369628, 4374488, 4380062, 4383663, 4388219, 4388220, 4389935, 4399222, 4400710; k) UDI/DI 15021312000436, Product Code/List Number/Item Code 60SP055, Lot Numbers: 3868322, 3901294, 3911430, 3936571, 3942470, 3948792, 3952344, 3952345, 3982716, 3988168, 3991214, 3991215, 4015615, 4015617, 4051626, 4066279, 4092632, 4110472, 4122437, 4128020, 4134026, 4145711, 4156618, 4161972, 4173739, 4180496, 4206851, 4209594, 4212797, 4223744, 4233985, 4247297, 4276489, 4279352, 4292186, 4322700, 4327889, 4335094, 4351256, 4374489, 4374490, 4380063, 4399223

Label field

Details supplied by the agency

Lot, code or applicability

a) UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056; b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers: 3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805; c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers: 3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930, d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers: 3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789; e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers: 3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 4327884, 4335084, 4345045, 4365784; f) UDI/DI 15021312000368, Product Code/List Number/Item Code 60SP030, Lot Numbers: , 3853491, 3853492, 3868316, 3877643, 3884256, 3894888, 3923735, 3952385, 3955780, 3965909, 3982711, 4001220, 4015600, 4021423, 4024939, 4051655, 4060225, 4077113, 4083929, 4086024, 4107575, 4116084, 4122451, 4131002, 4139003, 4142430, 4153593, 4161992, 4168181, 4171559, 4176237, 4185437, 4196300, 4204828, 4206846, 4209590, 4217452, 4221361, 4247296, 4254287, 4279350, 4283260, 4286823, 4335085, 4345046, 4369626, 4374484, 4382718, 4388214, 4389931, 4395806, 4400704; g) UDI/DI 15021312000375, Product Code/List Number/Item Code 60SP035, Lot Numbers: 3840044, 3853493, 3853494, 3868228, 3868229, 3884268, 3897848, 3907968, 3911420, 3926971, 3949027, 3952407, 3952408, 3955774, 3965910, 3982712, 3988164, 3988165, 3991210, 4005685, 4012662, 4018528, 4026679, 4034946, 4034947, 4056229, 4066278, 4077085, 4083940, 4085994, 4095919, 4107587, 4110471, 4119115, 4130987, 4139019, 4145700, 4151028, 4156660, 4161959, 4161960, 4176210, 4197629, 4206847, 4209591, 4212794, 4218724, 4226272, 4233983, 4240167, 4254288, 4260080, 4276485, 4283261, 4286824, 4289500, 4292185, 4322693, 4322695, 4335086, 4335087, 4335088, 4351253, 4352807, 4369623, 4369624, 4369625, 4382710, 4388215, 4389932, 4393428, 4393429; h) UDI/DI 15021312000382, Product Code/List Number/Item Code 60SP040, Lot Numbers: 3840061, 3853495, 3853496, 3861152, 3868210, 3868211, 3868212, 3894897, 3897846, 3907967, 3911423, 3930038, 3936574, 3946288, 3946289, 3946290, 3948791, 3949042, 3952338, 3952339, 3952340, 3955796, 3955797, 3982713, 3988166, 3991211, 3991212, 3997825, 4001221, 4015603, 4015605, 4015606, 4015608, 4026691, 4035769, 4041966, 4051661, 4056239, 4063194, 4070854, 4077066, 4083936, 4089288, 4092646, 4100889, 4107586, 4113097, 4119109, 4122427, 4130975, 4134011, 4142438, 4145678, 4151024, 4153604, 4159987, 4163838, 4171562, 4171563, 4176204, 4179372, 4185438, 4196301, 4201398, 4204829, 4206848, 4209592, 4212795, 4218725, 4221362, 4237399, 4240168, 4240169, 4254289, 4254290, 4273444, 4276486, 4283262, 4286825, 4289501, 4322696, 4322697, 4327952, 4335089, 4335090, 4348790, 4348791, 4351254, 4352806, 4353058, 4369629, 4369630, 4374485, 4374486, 4380061, 4383660, 4383661, 4388216, 4389933; i) UDI/DI 15021312000399, Product Code/List Number/Item Code 60SP045, Lot Numbers: 3840064, 3853497, 3868193, 3868194, 3868196, 3887754, 3894901, 3897885, 3911439, 3930048, 3942488, 3948793, 3952352, 3952353, 3952354, 3955808, 3959300, 3962575, 3982714, 3997826, 4001222, 4011387, 4015609, 4015610, 4035770, 4051647, 4056253, 4066297, 4077080, 4080782, 4089290, 4095915, 4105247, 4113116, 4119114, 4122452, 4130985, 4142432, 4145695, 4147994, 4153601, 4159988, 4161995, 4161996, 4168146, 4179373, 4185439, 4197630, 4201400, 4204830, 4209595, 4212796, 4216339, 4217453, 4221363, 4233984, 4233987, 4237400, 4254291, 4260081, 4276487, 4283263, 4286826, 4289502, 4335091, 4335092, 4345047, 4348793, 4348794, 4348795, 4348796, 4357227, 4357228, 4362881, 4362882, 4374487, 4381039, 4382711, 4383662, 4388217, 4388218, 4389934, 4393431, 4399221; j) UDI/DI 15021312000405, Product Code/List Number/Item Code 60SP050, Lot Numbers: 3840086, 3853498, 3868219, 3887748, 3897855, 3907970, 3942494, 3949034, 3952382, 3952383, 3962579, 3982715, 3988167, 3997827, 4001223, 4015611, 4015613, 4027992, 4027993, 4040760, 4053719, 4066285, 4089299, 4100886, 4113120, 4125829, 4134017, 4145722, 4147983, 4156662, 4163817, 4173738, 4179374, 4180461, 4196302, 4206849, 4209593, 4216340, 4218726, 4233986, 4254292, 4254293, 4273445, 4276488, 4279351, 4289503, 4322699, 4327950, 4335093, 4351255, 4352805, 4369627, 4369628, 4374488, 4380062, 4383663, 4388219, 4388220, 4389935, 4399222, 4400710; k) UDI/DI 15021312000436, Product Code/List Number/Item Code 60SP055, Lot Numbers: 3868322, 3901294, 3911430, 3936571, 3942470, 3948792, 3952344, 3952345, 3982716, 3988168, 3991214, 3991215, 4015615, 4015617, 4051626, 4066279, 4092632, 4110472, 4122437, 4128020, 4134026, 4145711, 4156618, 4161972, 4173739, 4180496, 4206851, 4209594, 4212797, 4223744, 4233985, 4247297, 4276489, 4279352, 4292186, 4322700, 4327889, 4335094, 4351256, 4374489, 4374490, 4380063, 4399223

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Sep 4, 2024
Recall initiation date: May 29, 2024
Center classification date: Aug 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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