BEUDAMED
    FDA Enforcement Class II Ongoing

    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

    Recall: Z-1341-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1341-2026
    Event ID
    98039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Laerdal Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2026
    Initiation Date
    January 13, 2026
    Classification Date
    February 11, 2026
    Address
    167 Myers Corners Rd, N/A, Wappingers Falls, NY, 12590-3869, United States

    Description

    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

    Reason

    units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.

    Code Info

    1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; UDI-DI: 07045432088519; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; UDI-DI: 07045432088533; 3) LCSU 4, RTCA; Catalog Number: 881152; UDI-DI: 07045432067132;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Denmark, Sweden, Norway, Canada, Finland, Australia, Spain, France, United Kingdom, Italy, Korea, Germany, Netherlands, Switzerland, New Zealand, Singapore, Malaysia, Austria.

    Quantity

    1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)