# FDA recall Z-2628-2023

> **Ambu Inc.** · Class II · device recall initiated 2023-07-21.

## Product

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system.    Catalog No: 405011000

## Reason for recall

Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2628-2023
- **Recalling firm:** Ambu Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-21
- **Report date:** 2023-10-04

- **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-2628-2023

## Citation

> AI Analytics. FDA recall Z-2628-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2628-2023. Source: US FDA. Licensed CC0.

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