Is this the product you have?

PORTEX Bivona Tracheostomy Silicone Tube, labeled as

7 of 7 products

Products covered by this recall
#	Product as published
1	PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025
2	PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030
3	PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035
4	PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040
5	PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045
6	PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050
7	PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

Lot codes and dates: 7 of 7 products
Products covered by this recall
# Barcodes Product as published
1 15021312005721 UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786, 3991203, 4015575, 4035758, 4083928, 4110465, 4156650, 4176238, 4209581, 4226268, 4254269, 4331631, 4335055, 4345041, 4348782, 4374468, 4374469, 4389923
2 15021312005738 UDI/DI 15021312005738, Product Code/List Number/Item Code 60P030, Lot Numbers: 3853478, 3868293, 3868294, 3884249, 3897861, 3904660, 3926961, 3936578, 3952364, 3952365, 3952366, 3959293, 3982699, 3997821, 4001215, 4011384, 4015576, 4024940, 4028385, 4040757, 4086004, 4092627, 4136145, 4145692, 4159935, 4185432, 4201393, 4206835, 4216332, 4216333, 4217450, 4223738, 4254270, 4273438, 4276478, 4286815, 4331632, 4335056, 4335057, 4374470, 4374471, 4382705, 4388203, 4389924, 4399210
3 15021312005745 UDI/DI 15021312005745, Product Code/List Number/Item Code 60P035, Lot Numbers: 3840043, 3853480, 3853481, 3864261, 3868247, 3871069, 3877659, 3880688, 3884267, 3891529, 3901310, 3904656, 3911424, 3920956, 3930014, 3939675, 3942522, 3952388, 3952389, 3952390, 3952391, 3959310, 3962581, 3982700, 3982701, 3988152, 3997822, 4001216, 4005677, 4008229, 4008230, 4011385, 4015577, 4026684, 4034945, 4034948, 4077086, 4083939, 4085993, 4095918, 4105252, 4110466, 4116092, 4128015, 4134012, 4134013, 4136146, 4139018, 4147997, 4151027, 4156605, 4163852, 4176208, 4179368, 4196294, 4201394, 4206836, 4209582, 4212790, 4218715, 4221356, 4223739, 4231518, 4237395, 4240163, 4247295, 4254273, 4260076, 4273439, 4276479, 4283252, 4283253, 4286816, 4292179, 4322686, 4327946, 4331633, 4331634, 4335058, 4335059, 4335060, 4335061, 4352799, 4369612, 4369613, 4369614, 4369615, 4374472, 4374473, 4380056, 4381033, 4382712, 4383654, 4388204, 4388206, 4389925, 4393424, 4395802
4 15021312005752 UDI/DI 15021312005752, Product Code/List Number/Item Code 60P040, Lot Numbers: 3840052, 3853482, 3853483, 3861126, 3868273, 3868274, 3874304, 3880711, 3884254, 3887756, 3894882, 3894883, 3904676, 3904677, 3911433, 3911434, 3923724, 3933477, 3939646, 3942486, 3946253, 3949021, 3952360, 3952361, 3952362, 3962569, 3962570, 3962571, 3962572, 3982702, 3988153, 3988154, 3991204, 4001217, 4005678, 4011386, 4015578, 4015580, 4029514, 4029515, 4035761, 4035762, 4035763, 4051642, 4051643, 4053701, 4077099, 4077100, 4082681, 4086016, 4086017, 4095923, 4107611, 4110467, 4113113, 4119089, 4122444, 4128026, 4130997, 4138995, 4142426, 4148005, 4153577, 4156635, 4161984, 4168172, 4179369, 4180501, 4195806, 4196293, 4201395, 4206837, 4206838, 4209583, 4217451, 4218716, 4218717, 4221357, 4226269, 4233979, 4237396, 4240164, 4254275, 4254277, 4273440, 4276480, 4279347, 4283254, 4283255, 4286817, 4289497, 4292180, 4322687, 4327944, 4335062, 4335063, 4335064, 4335065, 4335066, 4348797, 4351249, 4351250, 4369616, 4369617, 4374474, 4374475, 4381034, 4382706, 4382707, 4382708, 4382713, 4382715, 4383655, 4388205, 4388207, 4389926, 4393425
5 15021312005769 UDI/DI 15021312005769, Product Code/List Number/Item Code 60P045, Lot Numbers: 3858169, 3861127, 3868289, 3868290, 3868291, 3884247, 3894909, 3897860, 3904658, 3907984, 3911428, 3911429, 3930056, 3942490, 3946246, 3949024, 3952377, 3952378, 3952379, 3952380, 3955769, 3982703, 3982704, 3982705, 3988155, 3988156, 3988157, 4001218, 4005679, 4008231, 4015582, 4018526, 4018527, 4023793, 4026673, 4029516, 4035764, 4051639, 4051640, 4053716, 4060205, 4071970, 4077069, 4077070, 4083907, 4086002, 4086003, 4092626, 4096837, 4107598, 4110468, 4119117, 4125816, 4130978, 4138991, 4142422, 4145691, 4151044, 4153613, 4159933, 4161970, 4168139, 4176217, 4180500, 4185433, 4195807, 4196295, 4197626, 4201396, 4206839, 4206840, 4209584, 4212791, 4216334, 4218718, 4218719, 4221358, 4226270, 4231519, 4237397, 4240165, 4240166, 4254278, 4260077, 4260078, 4273441, 4276481, 4283256, 4286818, 4289498, 4292181, 4322688, 4331635, 4331636, 4335067, 4335068, 4335069, 4352800, 4352801, 4352802, 4357224, 4357226, 4374476, 4374477, 4374478, 4381035, 4381036, 4382714, 4383656, 4388208, 4388209, 4389927
6 15021312005776 UDI/DI 15021312005776, Product Code/List Number/Item Code 60P050, Lot Numbers: 3853484, 3853485, 3868201, 3868202, 3871066, 3884260, 3891527, 3894890, 3904663, 3904664, 3907966, 3918021, 3918022, 3926969, 3942507, 3946271, 3946272, 3952401, 3952402, 3952403, 3955781, 3982706, 3982707, 3982708, 3988158, 3988159, 3988160, 3988161, 3991205, 3997823, 4005680, 4005681, 4005682, 4009521, 4015583, 4015586, 4015587, 4027994, 4027995, 4040758, 4040759, 4077068, 4080313, 4085997, 4085998, 4092634, 4097839, 4107583, 4107584, 4113118, 4122446, 4125824, 4136147, 4139000, 4147981, 4151023, 4159937, 4168184, 4173735, 4179370, 4196296, 4204825, 4206843, 4209585, 4209586, 4216335, 4218720, 4218721, 4221359, 4226271, 4233980, 4254279, 4254280, 4273442, 4276482, 4279348, 4283257, 4283258, 4286819, 4289496, 4292182, 4322689, 4327947, 4331637, 4335070, 4335071, 4335072, 4335073, 4345042, 4351251, 4352804, 4369620, 4369621, 4369622, 4374479, 4374480, 4380057, 4382709, 4383657, 4388210, 4388211, 4389928, 4393426, 4395804, 4399218, 4400699, 4400700
7 15021312005783 UDI/DI 15021312005783, Product Code/List Number/Item Code 60P055, Lot Numbers: 3853487, 3853488, 3868223, 3880715, 3897864, 3908004, 3908005, 3923725, 3930031, 3936576, 3939631, 3942495, 3949031, 3952372, 3952373, 3952374, 3955790, 3982709, 3982710, 3988162, 3988163, 3991206, 3991207, 4001219, 4005683, 4005684, 4015588, 4015590, 4015591, 4015592, 4048027, 4051649, 4053708, 4066296, 4071976, 4077092, 4080784, 4083916, 4091395, 4105255, 4107591, 4113096, 4122455, 4130992, 4142434, 4145699, 4153620, 4159968, 4168153, 4173736, 4180465, 4185434, 4201397, 4204826, 4206844, 4209587, 4212792, 4216336, 4218722, 4223740, 4233981, 4254281, 4254282, 4254283, 4273443, 4276483, 4279349, 4283259, 4286820, 4289499, 4292183, 4322690, 4327941, 4327942, 4335075, 4335076, 4335077, 4351252, 4352803, 4374481, 4374482, 4374483, 4380058, 4380059, 4380060, 4381037, 4382716, 4383658, 4388212, 4388213, 4389929, 4393427, 4399217, 4399219

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.

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60 in total.

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`15021312005721`	UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786, 3991203, 4015575, 4035758, 4083928, 4110465, 4156650, 4176238, 4209581, 4226268, 4254269, 4331631, 4335055, 4345041, 4348782, 4374468, 4374469, 4389923
2	`15021312005738`	UDI/DI 15021312005738, Product Code/List Number/Item Code 60P030, Lot Numbers: 3853478, 3868293, 3868294, 3884249, 3897861, 3904660, 3926961, 3936578, 3952364, 3952365, 3952366, 3959293, 3982699, 3997821, 4001215, 4011384, 4015576, 4024940, 4028385, 4040757, 4086004, 4092627, 4136145, 4145692, 4159935, 4185432, 4201393, 4206835, 4216332, 4216333, 4217450, 4223738, 4254270, 4273438, 4276478, 4286815, 4331632, 4335056, 4335057, 4374470, 4374471, 4382705, 4388203, 4389924, 4399210
3	`15021312005745`	UDI/DI 15021312005745, Product Code/List Number/Item Code 60P035, Lot Numbers: 3840043, 3853480, 3853481, 3864261, 3868247, 3871069, 3877659, 3880688, 3884267, 3891529, 3901310, 3904656, 3911424, 3920956, 3930014, 3939675, 3942522, 3952388, 3952389, 3952390, 3952391, 3959310, 3962581, 3982700, 3982701, 3988152, 3997822, 4001216, 4005677, 4008229, 4008230, 4011385, 4015577, 4026684, 4034945, 4034948, 4077086, 4083939, 4085993, 4095918, 4105252, 4110466, 4116092, 4128015, 4134012, 4134013, 4136146, 4139018, 4147997, 4151027, 4156605, 4163852, 4176208, 4179368, 4196294, 4201394, 4206836, 4209582, 4212790, 4218715, 4221356, 4223739, 4231518, 4237395, 4240163, 4247295, 4254273, 4260076, 4273439, 4276479, 4283252, 4283253, 4286816, 4292179, 4322686, 4327946, 4331633, 4331634, 4335058, 4335059, 4335060, 4335061, 4352799, 4369612, 4369613, 4369614, 4369615, 4374472, 4374473, 4380056, 4381033, 4382712, 4383654, 4388204, 4388206, 4389925, 4393424, 4395802
4	`15021312005752`	UDI/DI 15021312005752, Product Code/List Number/Item Code 60P040, Lot Numbers: 3840052, 3853482, 3853483, 3861126, 3868273, 3868274, 3874304, 3880711, 3884254, 3887756, 3894882, 3894883, 3904676, 3904677, 3911433, 3911434, 3923724, 3933477, 3939646, 3942486, 3946253, 3949021, 3952360, 3952361, 3952362, 3962569, 3962570, 3962571, 3962572, 3982702, 3988153, 3988154, 3991204, 4001217, 4005678, 4011386, 4015578, 4015580, 4029514, 4029515, 4035761, 4035762, 4035763, 4051642, 4051643, 4053701, 4077099, 4077100, 4082681, 4086016, 4086017, 4095923, 4107611, 4110467, 4113113, 4119089, 4122444, 4128026, 4130997, 4138995, 4142426, 4148005, 4153577, 4156635, 4161984, 4168172, 4179369, 4180501, 4195806, 4196293, 4201395, 4206837, 4206838, 4209583, 4217451, 4218716, 4218717, 4221357, 4226269, 4233979, 4237396, 4240164, 4254275, 4254277, 4273440, 4276480, 4279347, 4283254, 4283255, 4286817, 4289497, 4292180, 4322687, 4327944, 4335062, 4335063, 4335064, 4335065, 4335066, 4348797, 4351249, 4351250, 4369616, 4369617, 4374474, 4374475, 4381034, 4382706, 4382707, 4382708, 4382713, 4382715, 4383655, 4388205, 4388207, 4389926, 4393425
5	`15021312005769`	UDI/DI 15021312005769, Product Code/List Number/Item Code 60P045, Lot Numbers: 3858169, 3861127, 3868289, 3868290, 3868291, 3884247, 3894909, 3897860, 3904658, 3907984, 3911428, 3911429, 3930056, 3942490, 3946246, 3949024, 3952377, 3952378, 3952379, 3952380, 3955769, 3982703, 3982704, 3982705, 3988155, 3988156, 3988157, 4001218, 4005679, 4008231, 4015582, 4018526, 4018527, 4023793, 4026673, 4029516, 4035764, 4051639, 4051640, 4053716, 4060205, 4071970, 4077069, 4077070, 4083907, 4086002, 4086003, 4092626, 4096837, 4107598, 4110468, 4119117, 4125816, 4130978, 4138991, 4142422, 4145691, 4151044, 4153613, 4159933, 4161970, 4168139, 4176217, 4180500, 4185433, 4195807, 4196295, 4197626, 4201396, 4206839, 4206840, 4209584, 4212791, 4216334, 4218718, 4218719, 4221358, 4226270, 4231519, 4237397, 4240165, 4240166, 4254278, 4260077, 4260078, 4273441, 4276481, 4283256, 4286818, 4289498, 4292181, 4322688, 4331635, 4331636, 4335067, 4335068, 4335069, 4352800, 4352801, 4352802, 4357224, 4357226, 4374476, 4374477, 4374478, 4381035, 4381036, 4382714, 4383656, 4388208, 4388209, 4389927
6	`15021312005776`	UDI/DI 15021312005776, Product Code/List Number/Item Code 60P050, Lot Numbers: 3853484, 3853485, 3868201, 3868202, 3871066, 3884260, 3891527, 3894890, 3904663, 3904664, 3907966, 3918021, 3918022, 3926969, 3942507, 3946271, 3946272, 3952401, 3952402, 3952403, 3955781, 3982706, 3982707, 3982708, 3988158, 3988159, 3988160, 3988161, 3991205, 3997823, 4005680, 4005681, 4005682, 4009521, 4015583, 4015586, 4015587, 4027994, 4027995, 4040758, 4040759, 4077068, 4080313, 4085997, 4085998, 4092634, 4097839, 4107583, 4107584, 4113118, 4122446, 4125824, 4136147, 4139000, 4147981, 4151023, 4159937, 4168184, 4173735, 4179370, 4196296, 4204825, 4206843, 4209585, 4209586, 4216335, 4218720, 4218721, 4221359, 4226271, 4233980, 4254279, 4254280, 4273442, 4276482, 4279348, 4283257, 4283258, 4286819, 4289496, 4292182, 4322689, 4327947, 4331637, 4335070, 4335071, 4335072, 4335073, 4345042, 4351251, 4352804, 4369620, 4369621, 4369622, 4374479, 4374480, 4380057, 4382709, 4383657, 4388210, 4388211, 4389928, 4393426, 4395804, 4399218, 4400699, 4400700
7	`15021312005783`	UDI/DI 15021312005783, Product Code/List Number/Item Code 60P055, Lot Numbers: 3853487, 3853488, 3868223, 3880715, 3897864, 3908004, 3908005, 3923725, 3930031, 3936576, 3939631, 3942495, 3949031, 3952372, 3952373, 3952374, 3955790, 3982709, 3982710, 3988162, 3988163, 3991206, 3991207, 4001219, 4005683, 4005684, 4015588, 4015590, 4015591, 4015592, 4048027, 4051649, 4053708, 4066296, 4071976, 4077092, 4080784, 4083916, 4091395, 4105255, 4107591, 4113096, 4122455, 4130992, 4142434, 4145699, 4153620, 4159968, 4168153, 4173736, 4180465, 4185434, 4201397, 4204826, 4206844, 4209587, 4212792, 4216336, 4218722, 4223740, 4233981, 4254281, 4254282, 4254283, 4273443, 4276483, 4279349, 4283259, 4286820, 4289499, 4292183, 4322690, 4327941, 4327942, 4335075, 4335076, 4335077, 4351252, 4352803, 4374481, 4374482, 4374483, 4380058, 4380059, 4380060, 4381037, 4382716, 4383658, 4388212, 4388213, 4389929, 4393427, 4399217, 4399219