# FDA recall Z-1575-2018

> **Vyaire Medical** · Class I · device recall initiated 2017-04-27.

## Product

AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

## Reason for recall

The mask component on various lots of the resuscitation devices have been identified as having the  potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the  mask from the elbow of the resuscitator.

## Distribution

Worldwide Distribution - US (Nationwide) and in the countries of  Canada, Puerto Rico, United Arab Emirates, Philippines, and  Europe.

## Key facts

- **Recall number:** Z-1575-2018
- **Recalling firm:** Vyaire Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-27
- **Report date:** 2018-05-16
- **Termination date:** 2019-05-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1575-2018

## Citation

> AI Analytics. FDA recall Z-1575-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1575-2018. Source: US FDA. Licensed CC0.

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