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U.S. Department of Health and Human Services

Class 2 Device Recall LAERDAL COMPACT SUCTION UNIT

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 Class 2 Device Recall LAERDAL COMPACT SUCTION UNITsee related information
Date Initiated by FirmJanuary 13, 2026
Date PostedFebruary 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1341-2026
Recall Event ID 98039
510(K)NumberK120065 
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
ProductLaerdal 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 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;
FEI Number 2425852
Recalling Firm/
Manufacturer		 Laerdal Medical Corporation
167 Myers Corners Rd
Wappingers Falls NY 12590-3869
For Additional Information Contact
845-297-7770
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JCX
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