Class IIReported 2026-02-18

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.

Recall Number

Z-1341-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-13

Reported

2026-02-18

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 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;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.