Manufacturer

Vyaire Medical

62 recalls in our database name Vyaire Medical as the manufacturing or recalling firm.

What the numbers show

Total: 62
Critical: 1
Severe: 13
Most recent: 2025-05-21

Of the 62 recalls from Vyaire Medical we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–62 of 62

HighFDA (Devices)·Z-1573-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1570-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 180 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1565-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,800 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,260 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1563-2018·2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,340 AirLife Pediatric Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot ad
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1554-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,058 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or can
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1562-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2018·2018-01-31
Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk
Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow into patient airways.
Product
Adult Air-Life single-limb circuit (Model AH202) 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 requiri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2018·2018-01-31
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.
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 patients
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2018·2018-01-31
Vyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife single-limb circuits and humidification chambers because a manufacturing error may cause water to back up into the patient's airway.
Product
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing 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 gas
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2018·2018-01-31
Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.
Product
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) 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 gasse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3080-2017·2017-09-06
Vyaire Medical Recalls AirLife Reduced Heparin Arterial Blood Samplers
Vyaire Medical is recalling specific lots of AirLife Reduced Heparin Arterial Blood Samplers because they contain incorrect sub-assemblies with larger needles, syringes, and heparin doses.
Product
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which incl
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Vyaire Medical (United States)

company in Lake Forest, United States

Country: United States
Founded: 2016

Official website

Source: Wikidata (Q106411856), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.