Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 31, 2018
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 patients requiring invasive and non-invasive ventilation.
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 exces…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vyaire Medical recalled Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Cham… - a critical-severity action.
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Cham… was recalled by Vyaire Medical in January 31, 2018. Reason: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The m…. Check the official notice for the remedy. Verify recall #Z-0346-2018 with the FDA Devices before acting.
The recall
Vyaire Medical issued this critical-severity FDA Devices recall-Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The m….
- Critical
- severity level
- 17K units
- affected scope
- Class I
- classification
- January 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0346-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0346-2018) was formally reported on January 31, 2018, with the manufacturer initiating the action on November 29, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Vyaire Medical is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records list the affected scope as 16,670 units in total.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
16,670 units in total
Related Recalls
6
3 from same agency
Product description
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 patients requiring invasive and non-invasive ventilation.
Reason for recall
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 ventilated patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0346-2018 |
| Date reported | January 31, 2018 |
| Date initiated | November 29, 2014 |
| Recalling firm | Vyaire Medical |
| Firm location | Vernon Hills, IL |
| Affected scope | 16,670 units in total |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0346-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 patients requiring invasive and non-invasive ventilation.. Recalled by Vyaire Medical. Units affected: 16,670 units in total.
Why was this product recalled? ▼
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 ventilated patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2018. Severity: Critical. Recall number: Z-0346-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0346-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 31, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.