Recall Z-1341-2026 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Laerdal Medical Corporation
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;
| Date | Feb 11, 2026 (initiated Jan 13, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 RTC |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES Plaxtron Industrial (M) Sdn. Bhd., Apr 3, 2012 |