Ambu recalls KING LTSD Size 1 airway kits for pediatric use without proper medical approval. This device may cause harm if used incorrectly in children. Contact Ambu for details.
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.
Ambu is recalling KING LTSD Size 1 airway kits that are designed for pediatric use without proper medical approval. Using these kits incorrectly in children could lead to serious health risks.
This airway kit is intended for pediatric use but lacks approval for that specific application. Using it without proper medical guidance could lead to complications in children.
Parents and caregivers of children who use this airway kit for medical purposes. Children receiving emergency airway care are most at risk.
Check for model number KLTSD431 or shipper label UD-DI 00612649212708. The kit is designed for inserting into a patient's pharynx through the mouth to provide an airway.
Look for model number KLTSD431 or shipper label UD-DI 00612649212708 on the kit.
The recall states this kit is intended for pediatric use but lacks approval for that specific application, so it may not be safe without medical guidance.
The recall does not specify a remedy, so contact Ambu directly for further instructions.
The kit introduces a new indication for pediatric use without proper medical approval, which could lead to complications in children.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-0274-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-0274-2025 from Ambu. 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.
