---
title: "PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY T... — FDA record Z-2604-2024 | 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-2604-2024-portex-bivona-tracheostomy-silicone-tube-labeled-as-a-paed-tracheostomy-tube-2-5mm-aire-cuf-product/
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) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N... — FDA record Z-2604-2024

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) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
- **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**: Not supplied
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2604-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2604-2024%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 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes: 3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619; b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes: 3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089; c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes: 3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735; d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes: 3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591; e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes: 3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620; f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes: 3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090, g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P055, Lot Codes: 3840082, 3871043, 3871044, 3901291, 3926980, 3942462, 3942463, 3952341, 3959335, 4011352, 4035681, 4056231, 4077094, 4083913, 4100882, 4107599, 4119123, 4134024, 4138988, 4153615, 4159942, 4168155, 4173721, 4180495, 4195801, 4213395, 4218688, 4267837, 4334869, 4344349, 4351229, 4351230, 4353075, 4389862, 4389863, 4400621 |

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-2604-2024%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/)