AirLife Manual Resuscitator recalled for broken components causing ventilation failure
Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation mandates a minimum severity score of 4. The defect risks improper ventilation, hypoventilation, and hypoxia in a critical life-support device.
Plain-English summary
Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators (model REF 2K8004) with 40-inch oxygen reservoir tubing and adult mask. The devices have been distributed worldwide, including in the United States, Brazil, Canada, Switzerland, France, the United Kingdom, Mexico, the Netherlands, Saudi Arabia, Sweden, and South Africa.
The duckbill and ring components in affected units may be broken or disassembled due to defective mold and tooling, resulting in out-of-specification parts. This defect may cause improper ventilation or complete failure to ventilate the patient.
Device failure may cause hypoventilation (inadequate breathing) or hypoxia (low blood oxygen), potentially leading to death. The recall affects all products manufactured on or before 2017, as well as any units without a documented manufacturing date. These units are identified by UDI-DI case code 50190752114102 or per-unit code 10190752114104. Vyaire Medical replaced the defective mold and tooling in 2017.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
- Manufacturer
- Vyaire Medical
- Hazard
- ventilation-failure
- hypoxia
- device-failure
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: 50190752114102
- Each: 10190752114104
- All manufacturing dates of 2017 and prior
- and any products without a manufacturing date.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03