BEUDAMED
    FDA Enforcement Class II Ongoing

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

    Recall: Z-2351-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2351-2026
    Event ID
    98907
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    June 17, 2026
    Initiation Date
    April 30, 2026
    Classification Date
    June 5, 2026
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-4667, United States

    Description

    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

    Reason

    Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

    Code Info

    Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342

    Distribution

    US Nationwide distribution.

    Quantity

    6,005 kits