---
title: "PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOM... — FDA record Z-2608-2024 | 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-2608-2024-portex-bivona-tracheostomy-silicone-tube-labeled-as-a-neonatal-tracheostomy-tube-2-5mm-tts-flextend/
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 2.5mm TTS FLEXTEND V FLANGE , Pro... — FDA record Z-2608-2024

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 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
- **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-2608-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2608-2024%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 10351688518736, Product Code/List Number/Item Code 67NFP25, Serial Numbers: 3936586, 4033699, 4091401, 4334881; b) UDI/DI 10351688518743, Product Code/List Number/Item Code 67NFP30, Serial Numbers: 3853379, 3864236, 3874314, 3884252, 3901302, 3930043, 3955792, 3962588, 3997790, 4011356, 4033700, 4063161, 4097823, 4116100, 4145705, 4163839, 4331551, 4334882, 4374402, 4380994; c) UDI/DI 10351688518750, Product Code/List Number/Item Code 67NFP35, Serial Numbers: 3853380, 3874302, 3891535, 3923730, 3939680, 3952399, 3959334, 4001123, 4021415, 4086018, 4110430, 4130984, 4151052, 4176229, 4218691, 4237346, 4331592, 4333982, 4357246, 4383594, 4388098, 4395737; d) UDI/DI 10351688518767Product Code/List Number/Item Code 67NFP40, Serial Numbers: 3853381, 3861138, 3894884, 3923727, 3952393, 3987930, 4033701, 4083924, 4122439, 4156634, 4237348, 4334883, 4388099 |

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-2608-2024%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/)