FDAClass II · Medical device · Recalled June 10, 2026

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code recall — Covidien LLC

Hazard: Due to customer complaint regarding incorrect display box labeling.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2261-2026
Brand: Covidien
Classification: Class II
Units affected: 1,002
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code

Companies & origin

Recalling firm location: Boulder, CO, United States
Firm address: 6135 Gunbarrel Ave, 80301-3214

Identifying details (verbatim from the notice)

Product codes / lots: Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
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.
Firm notified the public via: Letter
FDA event ID: 98813
Recall initiated: April 15, 2026
FDA classified: May 29, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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