Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the limitations to the 510 (k) exemption...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact King Systems Corp. dba Ambu, Inc. directly.
Affected Products
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
Quantity: 21591 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About King Systems Corp. dba Ambu, Inc.
King Systems Corp. dba Ambu, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report