Vyaire Medical: Medical Device Recall in 2024 - (Recall #: Z-1064-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 10, 2024

Date Posted: March 6, 2024

Recall Number: Z-1064-2024

Event ID: 93821

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.

Status: Ongoing

Product Quantity: 1,020,330 units

Code Information:

UDI/DI Case: 50190752114294, Each: 10190752114296; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated