Ambu recalls a specific model of broncho sampler set due to incorrect labeling that could lead to confusion about device size. Affected units have mismatched front and back labels.
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
Ambu is recalling a specific broncho sampler set model because the front label incorrectly states the device size as 5.0/2.2 instead of the actual 5.6/2.8. This mismatch could cause confusion during medical use, potentially leading to improper application.
The front label of the sampler set incorrectly states the device size as 5.0/2.2, while the back label, shipping box, and product inside correctly state 5.6/2.8. This mismatch could cause confusion during medical procedures, potentially leading to improper device application.
Healthcare professionals using the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set model 622002000US are most at risk. Patients using this device may also be affected if the incorrect labeling leads to improper use.
Check for the model number 622002000US on the product. The front label shows 5.0/2.2 while the back label, shipping box, and product inside show 5.6/2.8.
Compare the front label (5.0/2.2) with the back label, shipping box, and product inside (5.6/2.8) to confirm the correct size.
The recall is due to incorrect labeling that could cause confusion about device size, but the product itself is not dangerous. The hazard is low risk as it does not involve immediate harm.
Look for the model number 622002000US. The front label states 5.0/2.2 while the back label, shipping box, and product inside state 5.6/2.8.
No action is required beyond checking the label accuracy. The product is safe to use if the correct size is confirmed.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-1723-2025 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-1723-2025 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.
