AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.
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: This is an FDA Class I recall, the highest agency classification, for a critical-care medical device that could fail to deliver life-sustaining ventilation. The defect creates substantial risk of hypoxia or death, though no injuries or deaths have been reported to date.
Plain-English summary
Vyaire Medical is recalling approximately 8,220 units of the AirLife Adult Manual Resuscitator (REF 2K8004F) worldwide, including units distributed in the United States, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
The recall affects devices with specific UDI codes manufactured in 2017 or earlier, or lacking a manufacturing date. A faulty mold or tooling defect produced out-of-specification components in the duckbill and ring assembly, which can break or disassemble during use.
Device failure may result in improper ventilation or complete loss of ventilation, risking hypoventilation and hypoxia in patients who depend on the resuscitator. Although the mold and tooling were replaced after 2017, units made before that date remain affected.
If you have an affected unit, contact Vyaire Medical for instructions on verification and replacement or return of the device.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
- Manufacturer
- Vyaire Medical
- Category
- Medical Device
- Affected units
- 8,220
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: 50190752114133
- Each: 10190752114135
- 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.
See all 9 products in this recall →Related recalls
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