Z-1341-2026 Class II Ongoing
FDA device recall Z-1341-2026 was initiated by Laerdal Medical Corporation on January 13, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units).
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- January 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units)
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.
Distribution Pattern
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.
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;