Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Recalled by Ambu Inc. Due to Incorrect labeling in which the front red pouch...

Date: April 7, 2025
Company: Ambu Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ambu Inc. directly.

Affected Products

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

Quantity: 160 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ambu Inc.

Ambu Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report