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# Vyaire Recalls Airlife Resuscitator
- URL: https://www.fdaweb.com/vyaire-recalls-airlife-resuscitator/
- Published: 2024-02-26T12:00:00.000Z
- Updated: 2026-09-14T14:23:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156426

Vyaire Medical has recalled (Class 1) its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing. An FDA [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=205565&ref=fdaweb.com) says the device presents a risk of hypoventilation “caused by duckbill and ring broken/disassembled… Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death.”

The notice says the faulty component was traced back to a 2017 change in the component’s mold/tooling which produced out-of-specification components. FDA says the reason for the recall is improper process controls.