AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation
Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls carry a minimum score of 4 per the rubric. While the defect could potentially lead to death, no illnesses or injuries have been reported. The serious nature of ventilation failure in a critical medical device combined with FDA Class I classification places this in the Severe category.
Plain-English summary
Vyaire Medical is recalling the AirLife Adult Manual Resuscitator with Variable Volume Oxygen Reservoir Tubing and Adult Mask (model REF 2K8017). The recall affects approximately 1,020,330 units manufactured in 2017 or earlier, as well as any units without a manufacturing date clearly marked.
The duckbill and ring components in the device can break or disassemble due to faulty mold and tooling that produced substandard components. When these components fail, the resuscitator may not deliver proper ventilation or may deliver no ventilation at all. This can result in hypoventilation or hypoxia, and could potentially lead to death.
The affected devices were distributed worldwide, including in the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa. The manufacturer states that the problematic mold and tooling were replaced in 2017.
This is a Class I FDA recall.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
- Manufacturer
- Vyaire Medical
- Category
- Medical Device
- Affected units
- 1,020,330
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI Case: 50190752114294
- Each: 10190752114296
- All manufacturing dates of 2017 and prior
- and any products without a manufacturing date.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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