Ambu recalls KING LTSD Size : Pediatric airway kits may pose risks when used beyond intended age groups. Affected kits have specific model numbers and shipper labels.
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 kits that may be used incorrectly for pediatric patients. This could lead to airway complications if not properly sized for the child's anatomy.
The kit is designed for adult airways but may be used in children without proper size verification. This can cause airway obstruction or injury if the device is too large for the child's throat.
Parents or caregivers of children using this airway kit for medical purposes are most at risk. The recall affects pediatric patients who may be incorrectly sized for the kit.
Check for model number KLTSD432 or shipper label 00612649212722/00612649212739 on the kit packaging. The kit is intended for adult airways but may be used in children.
Look for model number KLTSD432 or shipper label 00612649212722/00612649212739 on the kit packaging.
The recall indicates the kit may not be safe for children as it was designed for adult airways. Pediatric use requires specific size verification.
The official recall does not specify a remedy, so check the model number and shipper label to confirm if it's affected.
The kit may pose risks when used in children beyond its intended design, potentially causing airway obstruction or injury.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-0275-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-0275-2025 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.
