Class II

Medical Device Recall: KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431

King Systems Corp. dba Ambu, Inc. · September 26, 2024

Reason for Recall

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Distribution

Nationwide

States Affected

NATIONWIDE

Quantity Affected

21591 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0274-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.