Recall Z-1341-2026— Laerdal Medical Corporation

Name: FDA recall Z-1341-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-13

Class II · Ongoing

Class II FDA medical device recall by Laerdal Medical Corporation, initiated 2026-01-13. It names one FDA 510(k) clearance: K120065. 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;. 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..

Recalling firm: Laerdal Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-01-13
Firm location: Wappingers Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K120065 — PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIESPlaxtron Industrial (M) Sdn. Bhd.·cleared 2012-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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;

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.