Laerdal Medical Corporation recalls Laerdal Compact Suction Unit 4 RTCA version

Recalling company

Laerdal Medical Corporation

Product

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 13, 2026

Reported

Feb 18, 2026

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.

Status

Ongoing

Quantity

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

Lot / codes

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;

Company location

Wappingers Falls, NY

Recall type

Voluntary: Firm initiated

Recall number

Z-1341-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1341-2026 in the FDA Enforcement Report. Also see FDA recall press releases.