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Open, Classified

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

FDA Recall Z-1723-2025 · Posted 2025-05-06

Recalling FirmAmbu Inc.
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2025-04-07
Product Quantity160 units

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.

Firm Action

Ambu notified sales representative first on 04/07/2025 with an "Urgent Field Safety Notice" letter and they are instructed to visit the affected accounts to notify them of the recall. The letter instructs customers to identify and quarantine any affected units on hand, to arrange for the return of affected units or destroy them on site, and to complete and return the response form.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2023-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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