FDA-Device2026-02-18Class IIPROCESSING DEFECT
Laerdal Compact Suction Unit 4 RTCA recalled for excess electromagnetic noise
What this means
Certain Laerdal Compact Suction Unit 4 RTCA models made during a specific time period may emit electromagnetic noise above acceptable levels for aircraft use. No injuries have been reported. The affected units have specific catalog numbers: 880052, 880062, or 881152.
- Check if your device matches one of the affected catalog numbers: 880052, 880062, or 881152
- Contact Laerdal Medical Corporation for instructions on how to proceed
- Do not use the unit until you confirm it is not affected
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)
Manufactured in
167 Myers Corners Rd, N/A, Wappingers Falls, NY, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1341-2026Want us to check the next one for you?
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