# FDA recall Z-0261-2025

> **Ambu Inc.** · Class II · device recall initiated 2024-09-16.

## Product

Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

## Reason for recall

Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.

## Distribution

US Nationwide. Canada.

## Key facts

- **Recall number:** Z-0261-2025
- **Recalling firm:** Ambu Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-16
- **Report date:** 2024-11-06

- **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-0261-2025

## Citation

> AI Analytics. FDA recall Z-0261-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0261-2025. Source: US FDA. Licensed CC0.

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