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

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