CLASS I Device recall · Reported 16 May 2018 · FDA Enforcement Report

AirLife Resuscitation, Infant, with mask, oxygen reservoir recalled

Vyaire Medical is recalling AirLife Resuscitation, Infant, with mask, oxygen reservoir, pressure-relief valve, PEEP, distributed nationwide in the US. The recall was initiated on 27 Apr 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Number: 2K8040. Lot: 0001073367

Quantity recalled180 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1581-2018
FDA event ID: 78412
Recalling firm: Vyaire Medical, Vernon Hills, IL
Classification: Class I
Status: Terminated
Recall initiated: 27 Apr 2017
FDA classified: 10 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

27 Apr 2017	Recall initiated by company
10 May 2018	Classified by FDA	+378 days
16 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Stores named: Walmart

Questions about this recall

Is AirLife Resuscitation, Infant, with mask, oxygen reservoir, pressure-relief valve, PEEP recalled?

Yes. Vyaire Medical recalled AirLife Resuscitation, Infant, with mask, oxygen reservoir, pressure-relief valve, PEEP on 27 Apr 2017. The recall is Class I and its status is Terminated. Recall number Z-1581-2018.

Why was it recalled?

Which lots are affected?

Part Number: 2K8040. Lot: 0001073367

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
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6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
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