CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report

Laerdal Compact Suction Unit 4 RTCA recalled by Laerdal Medical

Laerdal Medical is recalling Laerdal Compact Suction Unit 4 RTCA, distributed nationwide in the US. The recall was initiated on 13 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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;

Quantity recalled1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1341-2026
FDA event ID: 98039
Recalling firm: Laerdal Medical, Wappingers Falls, NY
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jan 2026
FDA classified: 11 Feb 2026
Reported: 18 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jan 2026	Recall initiated by company
11 Feb 2026	Classified by FDA	+29 days
18 Feb 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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;

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Laerdal Medical

All 3

Reported	Class	Recall	Company	Reason	Where
21 Mar 2018Device	CLASS II	Lcsu 4, Laerdal Compact Suction Unit The Lcsu recalled	Laerdal Medical	Other	Nationwide
26 Apr 2017Device	CLASS II	Laerdal Compact Suction Unit ¿ 4 under the following recalled	Laerdal Medical	Other	Nationwide

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