Vyaire Medical: Medical Device Recall in 2018 - (Recall #: Z-1566-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief 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.

Product Classification:

Class I

Date Initiated: April 27, 2017

Date Posted: May 16, 2018

Recall Number: Z-1566-2018

Event ID: 78412

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.

Status: Terminated

Product Quantity: 3,600 units

Code Information:

Part Number: 2K8021. Lots: 0001010402, 0001022520, 0001018798, 0001054821, 0001058109, 0001064428, 0001073364, 0001075035, 0001082390

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated