# FDA recall Z-2261-2026

> **Covidien LLC** · Class II · device recall initiated 2026-04-15.

## Product

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN  UDI-DI code: 60884522007028    The devices are intended for use in providing tracheal access for airway management.  Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable  inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley  Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of  polyvinyl chloride.

## Reason for recall

Due to customer complaint regarding incorrect display box labeling.

## Distribution

Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.

## Key facts

- **Recall number:** Z-2261-2026
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-15
- **Report date:** 2026-06-10

- **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-2261-2026

## Citation

> MORVS. FDA recall Z-2261-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2261-2026. Source: US FDA. Licensed CC0.

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