# FDA recall Z-1064-2024

> **Vyaire Medical** · Class I · device recall initiated 2024-01-10.

## Product

AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

## Reason for recall

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

## Distribution

Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

## Key facts

- **Recall number:** Z-1064-2024
- **Recalling firm:** Vyaire Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-10
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mettawa, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2024

## Citation

> AI Analytics. FDA recall Z-1064-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1064-2024. Source: US FDA. Licensed CC0.

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