Class II

Medical Device Recall: AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

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

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0269-2025

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.

King Systems Corp. dba Ambu, Inc. Medical Device Recall: AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420 | SafeCheck