BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1583-2026 · Initiated February 16, 2026

    Recall

    Recall Number
    Z-1583-2026
    Event Number
    98455
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    FON
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 16, 2026
    Posted
    March 19, 2026
    Address
    7815 National Service Rd, Ste 600, Greensboro, NC, 27409-9403

    Description

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

    Reason

    Drainable large pouch may leak due to manufacturing issue.

    Action

    On February XX, 2026 Convatec issued a updated Urgent Medical Device Recall Notification via E-Mail. The initial notification was issued February 16, 2026. Convatec asked consignees to take the following actions: 1. Review your personal supplies and determine if you are affected by this communication. 2. Discontinue use and dispose of the affected product. 3. Complete Response Form and return to Convatec within 30 days. 4. Acknowledgment of this action is critical. If you re not able to provide a written response liaise with your distributor or Convatec Customer Services can support. 5. Customer care team is available to assist you with any questions and provide product alternatives if needed. Please contact the regional Convatec Customer Services [email protected] Distributor: 1. Notify all downstream customers who may have received affected product. This letter may be used to support transmission of the communication. 2. For additional instructions reference customer notification

    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.