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Recall Observatory FDA recall evidence

Device product

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Z-1723-2025

April 07, 2025

Class II

Product summary

Firm
Ambu Inc.
Event
Event 96649
Status
Ongoing
Classification
Class II
Quantity
160 units
Official record key
device-enforcement:Z-1723-2025

Official wording

Reason: 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.

Code information: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Incorrect labeling