# FDA recall Z-1420-2022

> **Ambu Inc.** · Class II · device recall initiated 2022-06-03.

## Product

Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000,   412371000,   412391000,   412411000

## Reason for recall

Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.

## Distribution

Domestic distribution nationwide.   Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK  Canada, Australia, New Zealand, Israel  .

## Key facts

- **Recall number:** Z-1420-2022
- **Recalling firm:** Ambu Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-03
- **Report date:** 2022-07-27

- **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-1420-2022

## Citation

> AI Analytics. FDA recall Z-1420-2022. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1420-2022. Source: US FDA. Licensed CC0.

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