King Ambu recalls pediatric oropharyngeal airways (KLTSD422: Size 2.5) due to potential pediatric use risks. Affected units sold with specific labels; contact for remedy.
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.
King Ambu recalls certain pediatric oropharyngeal airways (size 2.5) because they may be used incorrectly in children. This could lead to serious injury if not properly sized for the patient.
These airways are designed for adult use but may be used in children without proper sizing. If the airway is too large, it could block the child's airway, causing breathing difficulties or injury.
Parents or caregivers of children who use these airways for medical purposes. Children with breathing difficulties may be at higher risk.
Check for model number KLTSD4225 on the packaging or label. Units sold with shipper label 00612649210193 or piece label 00612649210209 are affected.
Look for model number KLTSD4225 or shipper/piece labels mentioned in the recall.
The airway may be used incorrectly in children, which could cause breathing difficulties or injury.
Check for model number KLTSD4225 or shipper label 00612649210193 or piece label 00612649210209.
The recall does not specify a remedy, so contact King Ambu for guidance.
We’ve drafted a message you can send King Systems Corp. dba Ambu, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0272-2025 — King Systems Corp. dba Ambu, Inc. King Systems Corp. dba Ambu, Inc. Hello, I own a King Systems Corp. dba Ambu, Inc. that is covered by recall Z-0272-2025 from King Systems Corp. dba Ambu, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
