# FDA recall Z-1390-2025

> **Covidien** · Class I · device recall initiated 2025-02-26.

## Product

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1390-2025
- **Recalling firm:** Covidien
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-26
- **Report date:** 2025-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boulder, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2025

## Citation

> AI Analytics. FDA recall Z-1390-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1390-2025. Source: US FDA. Licensed CC0.

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