Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking
Vyaire Medical is recalling 3,600 AirLife Infant Resuscitators 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 used for life-support ventilation where a mechanical failure (mask sticking) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Vyaire Medical is recalling 3,600 units of AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, and pressure-relief 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 was initiated because the mask component on various lots has been identified as having the potential to exhibit a sticking condition. This issue may result in a difficult or unable to disconnect condition of the mask from the elbow of the resuscitator.
The affected devices were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8021, and the affected lot numbers are 0001010402, 0001022520, 0001018798, 0001054821, 0001058109, 0001064428, 0001073364, 0001075035, and 0001082390.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequatel
- Manufacturer
- Vyaire Medical
- Affected units
- 3,600
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)
- Part Number: 2K8021. Lots: 0001010402
- 0001022520
- 0001018798
- 0001054821
- 0001058109
- 0001064428
- 0001073364
- 0001075035
- 0001082390
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 failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28