Ambu recalls KING LTSD Size 2.5 airway kits for pediatric use. The device may cause airway injury if used beyond intended pediatric applications.
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 2.5 airway kits that are designed for pediatric use. These kits could cause airway injury if used incorrectly for non-pediatric patients.
The device is intended for pediatric airways only. Using it on non-pediatric patients could cause airway injury due to improper sizing or application.
Healthcare providers using the KING LTSD Size 2.5 airway kits for pediatric patients. Patients receiving care with these kits are at risk if misused.
Look for the model number KKLTSD4325 on the kit. The shipper label has UD-DI 00612649212746 and piece label 00612649212753.
Verify the model number KKLTSD4325 and UD-DI labels on the kit.
The recall states the device is intended for pediatric use only. Using it on adults could cause airway injury.
Check for model number KKLTSD4325 and UD-DI labels 00612649212746 (shipper) or 00612649212753 (piece).
The recall does not specify a remedy, so check with Ambu for guidance.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-0276-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-0276-2025 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.
