---
title: "PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOM... — FDA record Z-2603-2024 | 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-2603-2024-portex-bivona-tracheostomy-silicone-tube-labeled-as-a-neonatal-tracheostomy-tube-product-code-list-n/
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) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C... — FDA record Z-2603-2024

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) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040
- **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-2603-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2603-2024%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 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857, 4383590; b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers: 3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373; c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers: 3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861; UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers: 3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376 |

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-2603-2024%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/)