The US Food and Drug Administration (FDA) has classified the recall of Vyaire’s respiratory support devices as Class I – the most serious type of recall.

The US company initiated the recall of its AirLife manual resuscitator devices on 6 December 2023. The FDA tagged the recall as Class I – meaning continued device use could result in serious injury or death – on 21 March 2024.

The recall covers more than six and a half million devices and includes nine products from Vyaire’s AirLife range. The devices are single patient-use resuscitators intended for respiratory support.

Vyaire initiated the recall following reports of patients not receiving enough ventilation, potentially resulting in hypoventilation or hypoxia. A total of 37 incidents were reported, including two injuries and two deaths.

Vyaire traced the issue to a manufacturing defect, which it corrected in 2017. However, devices distributed before then could still be in use.

In a letter to customers, the company said to discard or destroy the AirLife manual resuscitators.

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Vyaire did not immediately respond to Medical Device Network for comment.

Respiratory devices have been a recurrent topic of conversation in recent years amid a slew of recalls. Philips has been one of the main companies under the spotlight following multiple recalls of its ventilator line. Draeger’s ventilators also faced issues, leading to a Class I recall in mid-2023. ResMed recalled more than 20 million of its continuous positive airway pressure (CPAP) masks in late 2023, with the FDA issuing a Class I recall tag in January 2024.

Medtronic caused ripples in the space earlier this year when the company announced it was exiting an “unprofitable” ventilator market.

A report by GlobalData estimates the global anaesthesia and respiratory devices market will grow to just over $19bn by 2033, up from $12.7bn in 2023.