Ambu recalls KING LTSD Size 2 airway devices for pediatric use risks. Devices may cause harm if used beyond intended medical 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 airway devices that are designed for pediatric use. This recall is due to a risk of harm if the device is used outside its intended medical purpose.
The device is intended for use in specific medical scenarios. Using it outside these scenarios could lead to harm, particularly in pediatric patients.
Healthcare professionals and pediatric patients who use these airway devices may be affected. Those using the device for purposes beyond its intended medical application are at higher risk.
Check for model number KLTSD422 or shipper label 00612649210186. The device is a sterile oropharyngeal airway inserted through the mouth to maintain an airway.
Look for model number KLTSD422 or shipper label 00612649210186 on the device packaging.
The device is intended for specific medical use cases, but the recall indicates potential risks if used outside its intended purpose.
The recall does not specify a remedy, so check with Ambu for guidance on safe use or disposal.
Look for model number KLTSD422 or shipper label 00612649210186 on the device packaging.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-0271-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-0271-2025 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.
