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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of…"
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…
- 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 Manual Resuscitator recalled for broken components causing ventilation failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
FDA (Devices) · 2024-03-06
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- 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
Similar recalls
- SevereVyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
FDA (Devices) · 2018-08-15
- SevereVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
- SevereAirLife Manual Resuscitator recalled for broken components causing ventilation failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk
FDA (Devices) · 2024-03-06
- SevereAirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
FDA (Devices) · 2024-03-06