# FDA recall Z-1723-2025

> **Ambu Inc.** · Class II · device recall initiated 2025-04-07.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1723-2025
- **Recalling firm:** Ambu Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-07
- **Report date:** 2025-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2025

## Citation

> AI Analytics. FDA recall Z-1723-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1723-2025. Source: US FDA. Licensed CC0.

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