BEUDAMED
    FDA Enforcement Class II Ongoing

    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

    Recall: Z-1583-2026 · Reported March 25, 2026

    Enforcement

    Recall Number
    Z-1583-2026
    Event ID
    98455
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 25, 2026
    Initiation Date
    February 16, 2026
    Classification Date
    March 19, 2026
    Address
    7815 National Service Rd Ste 600, N/A, Greensboro, NC, 27409-9403, United States

    Description

    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

    Reason

    Drainable large pouch may leak due to manufacturing issue.

    Code Info

    UDI: 00768455221363 Lot: 5K01728

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

    Quantity

    N/A