BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-2261-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2261-2026
    Event ID
    98813
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    April 15, 2026
    Classification Date
    May 29, 2026
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States

    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.

    Reason

    Due to customer complaint regarding incorrect display box labeling.

    Code Info

    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.

    Quantity

    1,002