Laerdal Medical Corporation Recalls Compact Suction Unit 4 Due to Electromagnetic Noise Interference

Source: FDA · Worldwide

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Laerdal Medical Corporation has issued a voluntary recall for specific LCSU 4 RTCA suction units that may emit electromagnetic noise exceeding safety limits for aviation environments.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.

What Happened

Laerdal Medical Corporation has initiated a voluntary recall of specific units of the Laerdal Compact Suction Unit 4 (LCSU 4) RTCA version. The affected units, manufactured during a limited time period, may emit electromagnetic noise that exceeds the acceptable limits for RTCA application as specified in RTCA DO-160G Chapter 21, Equipment Category M. This defect was identified as a Class II recall by the FDA.

Which Products Are Affected

The recall affects a total of 1,202 units (537 in the United States and 665 internationally). The following models and catalog numbers are included:

  • LCSU 4, 800 ml, RTCA: Catalog Number 880052; UDI-DI 07045432088519
  • LCSU 4, 300 ml, RTCA: Catalog Number 880062; UDI-DI 07045432088533
  • LCSU 4, RTCA: Catalog Number 881152; UDI-DI 07045432067132

These products were distributed worldwide, including the United States, Canada, Australia, and various countries across Europe and Asia.

What You Should Do

Laerdal Medical Corporation began notifying customers via letter on January 13, 2026. Consumers and healthcare facilities possessing the affected catalog numbers should follow the instructions provided in the firm's notification letter. For further information regarding returns or technical guidance, contact Laerdal Medical Corporation at their Wappingers Falls, NY headquarters.

Why This Matters

Excessive electromagnetic noise can interfere with the operation of other sensitive electronic equipment. In aviation and medical environments where RTCA standards are required, this interference could potentially impact critical systems.

Source

FDA Recall Z-1341-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Laerdal Medical Corporation has issued a voluntary recall for specific LCSU 4 RTCA suction units that may emit electromagnetic noise exceeding safety limits for aviation environments.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.