Z-1341-2026Class II

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

Name: Z-1341-2026 Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2)...
Creator: Laerdal Medical Corporation
Published: 2026-01-13
License: https://open.fda.gov/license/

Laerdal Medical a/S / initiated 2026-01-13 / Open, Classified / root cause: manufacturing process

FDA source

Laerdal Medical Corporation began a recall of 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)... on 2026-01-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1341-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-13
Posted: 2026-02-11
Recalling firm: Laerdal Medical a/S
Product: 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;
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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 Zealand, Singapore, Malaysia, Austria.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1341-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1341-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11

Product code JCX

K120065Class IIPlaxtron Suction Unit, Model 88Aa51/88aa61 SeriesPlaxtron Industrial (M) Sdn. Bhd. / cleared 2012-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)