AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation
Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.
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: The device is classified as FDA Class I, which requires a minimum severity of Severe. Although no injuries or deaths have been reported, component failure directly prevents adequate oxygen delivery, potentially causing hypoxia and death in a critical emergency ventilation device.
Plain-English summary
Vyaire Medical is recalling 66,078 units of the AirLife Adult Manual Resuscitator oxygen reservoir tubing (40 inches, REF 2K8001) manufactured in 2017 or earlier, or any units without a manufacturing date. The product has been distributed worldwide, including to healthcare facilities in the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
The duckbill valve and ring components in affected units may break or separate from the assembly due to manufacturing defects in the mold and tooling used to produce these parts. The defective mold and tooling were replaced in 2017.
Device failure in these units can result in improper ventilation or complete loss of ventilation to patients. This may lead to hypoventilation (inadequate breathing) and hypoxia (oxygen deprivation), potentially causing serious injury or death.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
- Manufacturer
- Vyaire Medical
- Affected units
- 66,078
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: 50190752114096
- Each: 10190752114098
- 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
Same manufacturer · Vyaire Medical
See all →- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk
FDA (Devices) · 2025-05-21
- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
FDA (Devices) · 2025-05-21
- SevereAirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator recalled for ventilation failure risk
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12