> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Covidien Recalls Shiley Tracheostomy Tube
- URL: https://www.fdaweb.com/covidien-recalls-shiley-tracheostomy-tube/
- Published: 2025-03-26T12:00:00.000Z
- Updated: 2026-09-14T14:56:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158901

Covidien has recalled (Class 1) its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns about a component potentially becoming disconnected. The device 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,” a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=212660&ref=fdaweb.com) says. Last month, the company notified users that patients with affected devices currently in place should be given a replacement device.