Ambu recalls pediatric oropharyngeal airway devices (KLTSD420) due to potential pediatric use risks. Affected units 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 certain pediatric oropharyngeal airway devices (LTSD size 0/1 with suction port) because they were designed for adult use but may be used on children. This could lead to serious harm if the device is not properly sized for the patient.
These devices were approved for adult use only but may be used on children. If the device is too large for a child's throat, it could cause airway obstruction or injury.
Healthcare providers who use Ambu oropharyngeal airways for patients, particularly those treating children. Pediatric patients at risk if the device is mistakenly used on a child.
Check for model KLTSD42: the product is sterile, has a suction port, and is labeled for oropharyngeal airway use. Units sold with UDI-DI numbers 00612649210131 or 00612649210148 are affected.
Look for model KLTSD42 with UDI-DI numbers 00612649210131 or 00612649210148 on the packaging or device.
The device was designed for adult use but may be used on children, which could cause airway obstruction or injury.
Check the device label for model KLTSD42 with UDI-DI numbers 00612649210131 or 00612649210148. If you have these, contact Ambu for guidance.
No, these devices are intended for adult use only. Using them on children could cause serious harm.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-0269-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-0269-2025 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.
