FDA DevicesClass II
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml...
Published: February 18, 2026Recall ID: Z-1341-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
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;
Affected Products
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;
Additional Source Details
| Field | Value |
|---|---|
| City | Wappingers Falls |
| State | NY |
| Event id | 98039 |
| Address 1 | 167 Myers Corners Rd |
| Address 2 | N/A |
| 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; |
| Postal code | 12590-3869 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 1202 units (537 US, 665 OUS) (2/23/2026: 574 US, 1239 units) |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260113 |
| Initial firm notification | Letter |
| Center classification date | 20260211 |
Overview
- Recalling FirmLaerdal Medical Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.