CLASS I ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report

Portex Bivona Tracheostomy Silicone Tube, labeled as recalled

Smiths Medical ASD is recalling Portex Bivona Tracheostomy Silicone Tube, labeled as: a) Tts Pediatric Trach Tube. The recall was initiated on 29 May 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129; d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers: 3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627; e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers: 3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628; f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers: 3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132; g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers: 3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2610-2024
FDA event ID: 94852
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class I
Status: Ongoing
Recall initiated: 29 May 2024
FDA classified: 23 Aug 2024
Reported: 4 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

29 May 2024	Recall initiated by company
23 Aug 2024	Classified by FDA	+86 days
4 Sep 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Portex Bivona Tracheostomy Silicone Tube, labeled as: a) Tts Pediatric Trach Tube recalled?

Yes. Smiths Medical ASD recalled Portex Bivona Tracheostomy Silicone Tube, labeled as: a) Tts Pediatric Trach Tube on 29 May 2024. The recall is Class I and its status is Ongoing. Recall number Z-2610-2024.

Why was it 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.

Which lots are affected?

a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129; d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers: 3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627; e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers: 3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628; f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers: 3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132; g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers: 3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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