AirLife Infant Heated Wire Circuit Adapter Disconnection Risk
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.
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 as FDA Class I, which per the rubric requires a minimum score of 4. The source describes risk of severe consequences (hypoxia, hypercapnia, organ failure) to vulnerable neonates from ventilation interruption, meeting the threshold for Severe.
Plain-English summary
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit, Model AH165, a dual-limb, dual-heat, high-flow respiratory circuit used to deliver gas between a patient and ventilator. The device is affected by a risk that adapters may disconnect during setup or while in use, which can interrupt ventilation to neonates.
Any disconnection of the adapter can result in severe consequences for infants, including hypoxia, hypercapnia, and organ failure. This FDA Class I recall affects 1895 units distributed worldwide, including across the United States and in Germany, Poland, Belgium, Spain, Romania, the United Kingdom, Italy, the Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Affected lots include: 0004240347, 0004240348, 0004252021, 0004253194, 0004253470, 0004255176, 0004260100, 0004262183, 0004262987, 0004263371, 0004292077, 0004300092, and 0004301668. If you have received this product, discontinue use immediately and contact Vyaire Medical or the FDA for further guidance.
The recalled product
- Product
- Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas…
- Manufacturer
- Vyaire Medical
- Affected units
- 1,895
Distribution
Distributed nationwide across the United States.
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 manual resuscitator component defect risks ventilation failure
FDA (Devices) · 2024-03-06
- 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 Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
Same hazard · adapter disconnection
See all →- SevereMedical Angiographic Control Syringes Recalled for Rotating Adapter Risk
FDA (Devices) · 2026-05-20
- HighPhilips Microstream Advance Neonatal-Infant CO2 Filter Line Adapter Disconnection Risk
FDA (Devices) · 2025-05-14
- HighCO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
FDA (Devices) · 2025-03-26
Similar recalls
- SevereVyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk
FDA (Devices) · 2018-01-31
- SevereVyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31
- SevereVyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31
- SevereVyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk
FDA (Devices) · 2018-01-31
- HighCareFusion AirLife Heated Infant Breathing Circuit Recalled for Material Change
FDA (Devices) · 2014-10-01
- SevereAirLife manual resuscitator component defect risks ventilation failure
FDA (Devices) · 2024-03-06