---
title: "Bivona: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Trach... — FDA announcement Sep 4, 2024 | Is It on Recall"
description: "The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect."
url: https://isitonrecall.com/recall/fdapress-99fb359084690fbd-bivona-bivona-r-aire-cuf-r-ttstm-uncuffed-mid-range-neonatal-pediatric-tracheostomy-tube-s-and-bivon/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Bivona: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TT... — FDA announcement Sep 4, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Sep 4, 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**: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)
- **Reason**: The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- **Classification**: Not supplied
- **Recalling firm**: Smiths Medical
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 99fb359084690fbd

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-notification-informing-customers-potential-issue-certain)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Smiths Medical Contact \| Contact Information \| Areas of Support; Global Complaint Management \| globalcomplaints@icumed.com 1-(866)-216-8806 \| To report adverse events or product complaints; Customer Service \| Customerservice@icumed.com 1-(800)-259-5361 \| Questions about your product and/or replacement |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| Smiths Medical Contact | Contact Information | Areas of Support |
| --- | --- | --- |
| Global Complaint Management | globalcomplaints@icumed.com 1-(866)-216-8806 | To report adverse events or product complaints |
| Customer Service | Customerservice@icumed.com 1-(800)-259-5361 | Questions about your product and/or replacement |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-notification-informing-customers-potential-issue-certain).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Sep 4, 2024
- **Company announcement date**: Aug 19, 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://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-notification-informing-customers-potential-issue-certain)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical records](https://isitonrecall.com/brand/smiths-medical/)