--- title: "PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE... — FDA record Z-2589-2024 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-2589-2024-portex-bivona-tracheostomy-silicone-tube-labeled-as-a-aire-cuf-trachy-tube-6-0mm-mid-range-product-c/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num... — FDA record Z-2589-2024 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180 - **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**: 25283 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2589-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2589-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458; b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers: 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 3839572, 3845070, 3849724, 3852697, 3870312, 3870313, 3870314, 3870315, 3870316, 3870317, 3870318, 3870319, 3897727, 3901072, 3901073, 3904426, 3939373, 3942402, 3952277, 3962454, 3973201, 3980528, 3988247, 3991258, 3991639, 4005726, 4008258, 4008259, 4008260, 4018554, 4021437, 4026720, 4033787, 4067208, 4070878, 4096871, 4097851, 4101024, 4107646, 4115311, 4117748, 4122529, 4128080, 4131075, 4134121, 4136191, 4139082, 4142533, 4145790, 4148043, 4151104, 4153681, 4171674, 4171675, 4173694, 4176260, 4178829, 4185497, 4192841, 4197661, 4197662, 4257859, 4263229, 4283185, 4309561, 4331671, 4363783, 4366576, 4376167, 4384907, 4393384; c) UDI/DI 15021312006421, Product Code/List Number/Item Code 750180, lot Numbers: 3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3797125, 3800602, 3801535, 3801536, 3801537, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3839573, 3839574, 3839575, 3870213, 3870214, 3870215, 3870216, 3870217, 3870218, 3870219, 3870220, 3870221, 3894701, 3894702, 3894703, 3894704, 3894705, 3894706, 3901032, 3901033, 3904488, 3904489, 3952216, 3952217, 3959218, 3962463, 3984950, 3988248, 4002283, 4002284, 4002285, 4005749, 4005750, 4015644, 4015645, 4021438, 4021439, 4033788, 4046816, 4054563, 4077143, 4080839, 4083962, 4092689, 4095943, 4096887, 4097852, 4105325, 4107661, 4110491, 4119152, 4125917, 4128114, 4131094, 4136209, 4139048, 4163867, 4168109, 4173695, 4178830, 4180539, 4185498, 4192842, 4192843, 4201737, 4205254, 4216366, 4229366, 4233997, 4242056, 4255460, 4291924, 4293044, 4331672, 4335537, 4346834, 4371674, 4371675, 4390913, 4391733, 4393385, 4393386, 4401163 | 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2589-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical ASD Inc. records](https://isitonrecall.com/brand/smiths-medical-asd-inc/)