# FDA recall Z-2553-2018

> **Vyaire Medical** · Class I · device recall initiated 2018-05-08.

## Product

AirLife Resuscitation Device, Pediatric labeled as the following:      a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018;      b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008;      c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D;      d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039     Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

## Reason for recall

An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

## Distribution

US distribution only  to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.

## Key facts

- **Recall number:** Z-2553-2018
- **Recalling firm:** Vyaire Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-08
- **Report date:** 2018-08-15
- **Termination date:** 2020-07-07

- **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-2553-2018

## Citation

> AI Analytics. FDA recall Z-2553-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2553-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*