BEUDAMED
    FDA Enforcement Class II Ongoing

    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

    Recall: Z-2275-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2275-2025
    Event ID
    97127
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2025
    Initiation Date
    June 20, 2025
    Classification Date
    August 6, 2025
    Address
    5010 Campuswood Dr Ste 102, N/A, East Syracuse, NY, 13057-1561, United States

    Description

    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

    Reason

    Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

    Code Info

    Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447

    Distribution

    US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

    Quantity

    2,800 pieces