Compact suction units recalled over electromagnetic noise above aviation limits
Laerdal Medical is recalling 1,202 Compact Suction Unit 4 RTCA units because those made in a limited period may emit electromagnetic noise beyond the acceptable RTCA limits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites electromagnetic emissions above an equipment specification, with no stated clinical consequence or reported harm.
Plain-English summary
The Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) is being recalled by Laerdal Medical Corporation, covering the LCSU 4 800 ml RTCA (catalog number 880052), the LCSU 4 300 ml RTCA (880062) and the LCSU 4 RTCA (881152).
The reason given in the enforcement record is that 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.
The record lists 1,202 units, of which 537 are in the US and 665 outside it, and notes a further figure of 1,239 units with 574 in the US as of 2/23/2026; both are reported here as printed. UDI-DI codes are recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Denmark, Sweden, Norway, Canada, Finland and other countries listed in the record. The FDA has classified the action as Class II.
The record cites an electromagnetic compatibility specification for airborne use and states no clinical consequence or reported injuries. Operators should follow Laerdal's instructions.
The recalled product
- 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;
- Manufacturer
- Laerdal Medical Corporation
- Category
- Medical Device — Suction unit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 1) LCSU 4
- 800 ml
- RTCA
- Catalog Number: 880052
- UDI-DI: 07045432088519
- 2) LCSU 4
- 300 ml
- Catalog Number: 880062
- UDI-DI: 07045432088533
- 3) LCSU 4
- Catalog Number: 881152
- UDI-DI: 07045432067132
Distribution
Distributed nationwide across the United States.
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