BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

    Recall: Z-1005-2026 · Initiated November 25, 2025

    Recall

    Recall Number
    Z-1005-2026
    Event Number
    98035
    Firm
    Ferndale Laboratories, Inc.
    FEI Number
    1811212
    Product Code
    KGX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 25, 2025
    Posted
    December 31, 2025
    Address
    780 W 8 Mile Rd, Ferndale, MI, 48220-2422

    Description

    Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

    Reason

    Butyrate tube cracks during actuation, rendering product unusable.

    Action

    On November 25, 2025, the firm issued Urgent Medical Device Recall letters to affected consignees. Consignees were instructed to quarantine Lot 24161B and return all units to Ferndale Laboratories.

    Distribution

    Worldwide distribution - US Nationwide and the country of UK.

    Quantity

    24589