Is this the product you have?

PORTEX Bivona Tracheostomy Silicone Tube, labeled as

11 of 11 products

Products covered by this recall
Model / number	Product as published
`2.5`	PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a)
`3.0`	UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b)
`3.5`	UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c)
`4.0`	UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d)
`2.5`	UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e)
`3.0`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f)
`3.5`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g)
`4.0`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h)
`4.5`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i)
`5.0`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j)
`5.5`	UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k)

Lot codes and dates: 11 of 11 products
Products covered by this recall
# Barcodes Product as published
1 15021312000115 UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056
2 15021312000122 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
3 15021312000139 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
4 15021312000184 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
5 15021312000344 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
6 15021312000368 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
7 15021312000375 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
8 15021312000382 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
9 15021312000399 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
10 15021312000405 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
11 15021312000436 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

This recall covers 28 products

The agency filed one notice per product. You are reading one of them; the other 27 are below.

15 more are in the archive.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Smiths Medical ASD Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Medical device recalls

Other recalls from Smiths Medical ASD Inc.

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a… Nov 6, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Oct 30, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Oct 2, 2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX Sep 18, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses… Aug 14, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b)… Apr 24, 2024

60 in total.

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`15021312000115`	UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056
2	`15021312000122`	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
3	`15021312000139`	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
4	`15021312000184`	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
5	`15021312000344`	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
6	`15021312000368`	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
7	`15021312000375`	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
8	`15021312000382`	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
9	`15021312000399`	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
10	`15021312000405`	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
11	`15021312000436`	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