Class I FDA device recall · Z-2615-2024

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers:   3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802;  b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers:   3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158;  c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers:  3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146;  d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers:  3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803;  e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160;    f) UDI/DI¿15021312000696,  Product Code/List Number/Item Code 67SP030, Lot Numbers:  3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654;  g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers:  3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655;  h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers:  3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079;   i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161;    j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers:  3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656;  k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers:   3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution.

Recall record

Recalling firm: Smiths Medical ASD Inc.
Product type: Devices
Recall number: Z-2615-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Minneapolis, MN
Recall initiated: 2024-05-29

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2615-2024 · Source: openFDA enforcement.