FDA recall, , Moderate risk
Laerdal Compact Suction Unit 4 RTCA Version
The Laerdal Compact Suction Unit 4 RTCA version may emit electromagnetic noise beyond acceptable limits.
Summary by Recall Canary from the FDA notice
What happened
Laerdal Medical Corporation of Wappingers Falls, New York, began a recall on January 13, 2026, of its Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA), including the LCSU 4, 800 ml, RTCA; the LCSU 4, 300 ml, RTCA; and the LCSU 4, RTCA. The units may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
The recall was added to the FDA's Enforcement Report and classified on February 11, 2026. The units were distributed worldwide, including nationwide in the US and in Denmark, Sweden, Norway, Canada, Finland, Australia, Spain, France, United Kingdom, Italy, Korea, Germany, Netherlands, Switzerland, New Zealand, Singapore, Malaysia, and Austria. The FDA reported 1202 units affected (537 US, 665 OUS).
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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;
- UDI-DI
- 07045432088519
- 07045432088533
- 07045432067132
Recall details
- Company began the recall
- Sold in
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.
- Company
- Laerdal Medical CorporationWappingers Falls, New York
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98039
- Recall number
- Z-1341-2026
- Quantity recalled
- 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
