Agency classClass IOur severity:Severe FDA (Devices)·Z-0346-2018·Announced 2018-01-31

Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk

Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.

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: "Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the…"

Plain-English summary

Vyaire Medical is recalling 16,670 units of the Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber (Model AH290). These devices are used to deliver heated and humidified respiratory gases to patients requiring invasive and non-invasive ventilation. The recall covers units distributed nationwide in the United States.

The recall is due to a manufacturing error in the humidification chamber that may cause an overfill or overflow condition. This defect can result in water backing up into the patient circuit, potentially allowing an excessive amount of water to enter the airway or lungs of a ventilated patient.

Healthcare facilities and consumers should stop using the affected devices immediately. Vyaire Medical is the recalling firm responsible for managing the recall. Specific lot codes are listed in the official recall documentation to identify affected units.

The recalled product

Product: Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to…
Manufacturer: Vyaire Medical
Category: Medical Device — Ventilation Equipment
Hazard: water-ingestion
manufacturing-error
Affected units: 16,670

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Vyaire Medical

See all →

Severe
AirLife Infant Heated Wire Circuit Adapter Disconnection Risk
FDA (Devices) · 2025-05-21
Severe
AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
FDA (Devices) · 2025-05-21
Severe
AirLife Manual Resuscitator recalled for broken components causing ventilation failure
FDA (Devices) · 2024-03-06
Severe
AirLife Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
Severe
AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
FDA (Devices) · 2024-03-06

Same hazard · water ingestion