Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as the defect poses a reasonable probability of serious adverse health consequences.
Plain-English summary
Vyaire Medical is recalling specific lots of AirLife Resuscitation Devices, Pediatric, due to a manufacturing error that has the potential to obstruct the airflow of supplemental oxygen delivery during use. The affected devices are manual resuscitation devices intended for single-patient use to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The recall covers 15,714 units distributed across 29 U.S. states and Puerto Rico. The specific part numbers and lot numbers affected are: Part Number 2K8018 (Lot 0001210201); Part Number 2K8008 (Lots 0001209831, 0001209837); Part Number RE1DK5445D (Lots 0004002563, 0004003205); and Part Number 2K8039 (Lot 0001209839).
Healthcare facilities and consumers should check their inventory for these specific part and lot numbers. If the devices are found, they should be removed from service and returned to Vyaire Medical for evaluation or replacement, as the obstruction risk could compromise the delivery of life-sustaining oxygen.
The recalled product
- Product
- AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric,
- Manufacturer
- Vyaire Medical
- Affected units
- 15,714
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 (9)
- a. Part Number 2K8018
- Lot Number 0001210201
- b. Part Number 2K8008 Lot Numbers 0001209831
- 0001209837
- c. Part Number RE1DK5445D
- Lot Numbers 0004002563
- 0004003205
- d. Part Number 2K8039
- Lot Number 0001209839
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Vyaire Medical
See all →- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
FDA (Devices) · 2025-05-21
- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk
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 · airflow obstruction
See all →- HighVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
- HighCardinal Health Recalls Presource Total Knee Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- HighCardinal Health Recalls Presource Anesthesia Circuit Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- HighCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15