Ambu Inc.: Medical Device Recall in 2025 - (Recall #: Z-1723-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 7, 2025

Date Posted: May 14, 2025

Recall Number: Z-1723-2025

Event ID: 96649

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 160 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated