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FDA (Device enforcement)Recalled 2026-01-13class ii

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

Hazard

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.

Details from the source

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. 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. Quantity: 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units) Lot/code info: 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;

UPC codes

07045432088519, 07045432088533, 07045432067132

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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