---
title: "Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C... — FDA record Z-1390-2025 | Is It on Recall"
description: "Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure,"
url: https://isitonrecall.com/recall/fda-device-z-1390-2025-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-reusable-inner-cannula-ref-7cn80r/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R — FDA record Z-1390-2025

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 Feb 26, 2025. 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**: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
- **Reason**: Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
- **Classification**: Class I
- **Recalling firm**: Covidien
- **Quantity**: 780
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1390-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1390-2025%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 | UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029 |

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

## Distribution

OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan

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

## Dates in the source

- **Report date**: Apr 2, 2025
- **Recall initiation date**: Feb 26, 2025
- **Center classification date**: Mar 25, 2025

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-1390-2025%22)

## Related records

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