AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk
Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.
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 classification combined with the serious nature of the hazard—device failure could result in hypoventilation, hypoxia, or death. Although no deaths or serious injuries are reported in the source, the classification and risk profile warrant a Severe rating.
Plain-English summary
Vyaire Medical has recalled 3,683,407 units of the AirLife Adult Manual Resuscitator with 40-inch oxygen reservoir tubing and adult mask (model REF 2K8005). The devices were distributed worldwide, including throughout the United States and internationally to Brazil, Canada, Switzerland, France, the UK, Mexico, the Netherlands, Saudi Arabia, Sweden, and South Africa.
The recall is due to a manufacturing defect in the duckbill and ring components. Faulty mold or tooling produced these components out of specification, causing them to break or become disassembled during use.
When these components fail, the device may deliver improper ventilation or no ventilation at all. This can result in hypoventilation or hypoxia, which may lead to serious harm or death.
The recall affects all units manufactured in 2017 or earlier, as well as any units without a manufacturing date. Healthcare facilities should immediately stop using affected devices and contact Vyaire Medical for replacement units or further information.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
- Manufacturer
- Vyaire Medical
- Affected units
- 3,683,407
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: 50190752114157
- Each: 10190752114159
- 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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