Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could impede the disconnection of the mask from the resuscitator. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Vyaire Medical is recalling 900 units of AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, and PEEP valve. These manual resuscitation devices are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The recall is due to a potential sticking condition in the mask component. This issue may result in a difficult or unable to disconnect condition of the mask from the elbow of the resuscitator.
The affected products are distributed worldwide, including the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8038, and the affected lots are 0001018799, 0001058107, and 0001085043.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathi
- Manufacturer
- Vyaire Medical
- Affected units
- 900
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 (3)
- Part Number: 2K8038. Lots: 0001018799
- 0001058107
- 0001085043
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 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 35 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 · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12