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Vyaire Medical recall records

11 reported ongoing

16 records in this archive. Latest source date Apr 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 du...

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Official source
FDA device enforcement

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Ki...

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

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...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

Official source
FDA device enforcement

vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Class IIReported completed

Distribution: US: Florida

Official source
FDA device enforcement

vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Class IIReported completed

Distribution: US: Florida

Official source
FDA device enforcement

bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occu...

Class IIReported completed

Distribution: US Nationwide Distribution

Official source
FDA device enforcement

bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occu...

Class IIReported completed

Distribution: US Nationwide Distribution

Official source
FDA device enforcement

bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure vent...

Potential cessation in ventilation can occur under specific conditions.

Class IReported terminated

Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI a...

Official source

Reasons in these listed records

  • Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
  • 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...
  • Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
  • Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user cont...

These examples come from this result page and are not a ranking of every recall reason.

Checking Vyaire Medical

Is there a recall on vyaire medical right now?

This archive contains 16 records, including 11 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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