Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 30

FDA device recall Z-1341-2026 · posted 2026-02-11 · Open, Classified

Recall details

Recalling firm

Laerdal Medical Corporation

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.

Action taken

On January 13, 2026, Medical Device Recall letters were sent to customers. Actions to be taken: 1. Please review this notice carefully and provide acknowledgment that you have received and understood the contents. If you received this notice from a distributor or other third party, please send your acknowledgment directly to Laerdal using the contact information provided below. You must provide the case number in the footer of this notice in your response. 2. Ensure that this notice is shared with all relevant personnel involved in the storage, maintenance, charging, and use of the LCSU 4 RTCA device. 3. Maintain this information for your records. As part of Laerdal s commitment to customer service, RTCA/DO-160G Section 21 Category M compliant replacement units are being offered, free of charge. To receive a replacement, you must reply within 2 weeks of receipt, with the following information: 1. Confirm acknowledgment of this notice as mentioned above. 2. Confirm serial numbers of your affected units, shipping address, and contact information in your reply. Once validated, Laerdal Medical will arrange for your affected unit(s) to be replaced at no cost. Important: Replacement units (881152) are shipped without a carry bag, battery, external power supply, wire stand, canister, or tubing. Please retain these accessories from your existing unit for continued use. Customers are required to confirm responsibility for disposing of the replaced LCSU 4 RTCA Unit(s) in accordance with applicable environmental regulations. Proof of disposal must be retained and made available upon request. By accepting the replacement, the customer releases Laerdal from any future claims or liabilities related to the old unit. Please maintain awareness of this notice and the related actions for your records. ***Update 03/24/2026***Additional recall letters were sent on or around 2/25/2026 to additional consignees identified by the recalling firm.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JCX

Quantity affected

1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)

Distribution

Worldwide distribution - US Nationwide and the countries of Denmark, Sweden, Norway, Canada, Finland, Australia, Spain, France, United Kingdom, Italy, Korea, Germany, Netherlands, Switzerland, New Zea

Date initiated

2026-01-13

Date posted

2026-02-11

Location

Wappingers Falls, NY

Related 510(k) clearances