BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

    Recall: Z-1187-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1187-2026
    Event ID
    98226
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 4, 2026
    Initiation Date
    December 12, 2025
    Classification Date
    January 28, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

    Reason

    Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

    Code Info

    Medline Kit SKU DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.

    Distribution

    US Nationwide distribution.

    Quantity

    1,928 total