Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog N...
FDA Recall #Z-1341-2026 — Class II — January 13, 2026
Product 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 for Recall
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.
Recalling Firm
Laerdal Medical Corporation — Wappingers Falls, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,202 units (537 US, 665 OUS)
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.
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated