Stop using now Medical device recall · FDA · Published January 10, 2024

Vyaire AirLife Resuscitator Recall: Risk of Hypoventilation from Faulty Components

Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen tubing that may cause hypoventilation or hypoxia, potentially leading to death. Affected units have manufacturing dates of 2017 or earlier.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1062-2024Medical device Vyaire Medical ›

Stop using this now

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

Take action

Contact the company

Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420

✎ GovInfoNow plain-language explainer

Vyaire Medical is recalling AirLife Adult Manual Resuscitators with oxygen reservoir tubing that may break, causing improper ventilation and potentially life-threatening hypoventilation. This recall affects units made in 2017 or earlier, which could lead to serious injury or death if not fixed. Read more at govinfonow.com/recall/56337-vyaire-airlife-resuscitator-recall-risk-of-hypoventilation-from-faulty-components.

Source Summary by GovInfoNow · govinfonow.com/recall/56337-vyaire-airlife-resuscitator-recall-risk-of-hypoventilation-from-faulty-components · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1062-2024

Cite this page

“Vyaire AirLife Resuscitator Recall: Risk of Hypoventilation from Faulty Components.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56337-vyaire-airlife-resuscitator-recall-risk-of-hypoventilation-from-faulty-components. Based on FDA recall #Z-1062-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1062-2024%22&limit=1).

The FDA announced on Jan. 10, 2024, that Vyaire Medical is recalling AirLife Adult Manual Resuscitator kits with 40-inch oxygen reservoir tubing due to a risk of hypoventilation or death from component failure. The agency classified the recall as Class I.

How to tell if you have it

Brand: Vyaire Medical
Product: AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter
REF: 2K8005F
UDI/DI Case: 50190752114188
UDI/DI Each: 10190752114180
Manufacturing dates: 2017 and prior, or no manufacturing date

The hazard

The recall addresses the risk of hypoventilation caused by a broken or disassembled duckbill and ring due to faulty mold tooling producing out-of-specification components. This device failure may cause improper ventilation or no ventilation, potentially leading to death.

Context

GovInfoNow's records show Vyaire Medical has issued nine other recalls since July 18, 2017. Other recent recalls of similar products include the AirLife Infant Heated Wire Circuit Recall (April 10, 2025), the Vyaire Flexible Patient Circuit 3100A recall (Oct. 27, 2023), and the Bellavista 1000e Ventilator Recall (May 5, 2023).

How to tell if you have this one

Check for manufacturing dates of 2017 or earlier. Products without a manufacturing date are also affected. The product includes a specific reference number (REF 2K8005F).

Brand
Vyaire Medical
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Recall number	Product, codes & lots	Quantity
Z-1057-2024	AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,; UDI/DI Case: 50190752114089, Each: 10190752114081; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	106,656 units
Z-1058-2024	AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001; UDI/DI Case: 50190752114096, Each: 10190752114098; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	66,078 units
Z-1059-2024	AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F; UDI/DI Case: 50190752114133, Each: 10190752114135; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	8,220 units
Z-1060-2024	AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2; UDI/DI Case: 50190752114119, Each: 10190752114111; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	3,636 units
Z-1061-2024	AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005; UDI/DI Case: 50190752114157, Each: 10190752114159; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	3,683,407 units
Z-1062-2024	AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F; UDI/DI Case: 50190752114188, Each: 10190752114180; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	2,070 units
Z-1063-2024	AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2; UDI/DI Case: 50190752114164, Each: 10190752114166; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	4,572 units
Z-1064-2024	AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017; UDI/DI Case: 50190752114294, Each: 10190752114296; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	1,020,330 units
Z-1065-2024	AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004; UDI/DI Case: 50190752114102, Each: 10190752114104; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.	1,800,000 units

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the AirLife Adult Manual Resuscitator if it has a manufacturing date of 2017 or earlier.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 56 days after the firm started it.

Jan 10, 2024Firm started the recall
Feb 24, 2024FDA classified it Class I
Mar 6, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56337-vyaire-airlife-resuscitator-recall-risk-of-hypoventilation-from-faulty-components">Vyaire AirLife Resuscitator Recall: Risk of Hypoventilation from Faulty Components (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1062-2024 (January 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1062-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.