Laerdal Compact Suction Unit 4 RTCA version (LCSU 4… recallZ-1341-2026 · Laerdal Medical Corporation · initiated Jan 13, 2026
Class II Open, Classified All recalls posted in February 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Laerdal Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1341-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 13, 2026
- Posted by the FDA
- Feb 11, 2026
- Recalling firm
- Laerdal Medical Corporation
- Quantity
- 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)
- Product code
- JCX
- FDA submissions
- K120065
- 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 Zealand, Singapore, Malaysia, Austria.
Product description
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;
Code information (models, lots, serial numbers)
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;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- LCSU 4, 800 ml, RTCA Complete Unit 880052Laerdal Medical AS · Apparatus, Suction, Ward Use, Portable, Ac-Powered1 recall0 reports
- LCSU 4, 300 ml, RTCA Complete Unit 880062Laerdal Medical AS · Apparatus, Suction, Ward Use, Portable, Ac-Powered1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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