Vernon Hills, IL, United States
Vyaire Medical recalls
12 recalls recorded since 2018, most recently on 10 April 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)3
Terminated or completed9
Class I (FDA)9
Ongoing Class I Medical devices
- Recall started
- 10 April 2025
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1697-2025, Z-1698-2025
- 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 dual-limb, dual-heat, high-flow circuit (
- 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 Kit Dual-limb, Dual-heat, high-flow circu
Ongoing Class I Medical devices
- Recall started
- 8 April 2024
- Reason
- Potential of the nozzle separating during patient use.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1730-2024
- Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube
Ongoing Class I Medical devices
- Recall started
- 10 January 2024
- Reason
- 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.
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1062-2024, Z-1064-2024, Z-1061-2024, Z-1060-2024, Z-1059-2024, Z-1063-2024, Z-1058-2024, Z-1057-2024, Z-1065-2024
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
- AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
- AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
- and 1 more product lines
Completed Class II Medical devices
- Recall started
- 27 October 2023
- Reason
- 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.
- Distribution
- US: Florida
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0489-2024, Z-0488-2024
- vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Completed Class II Medical devices
- Recall started
- 5 May 2023
- Reason
- 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 continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1967-2023, Z-1966-2023
- bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
- bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Terminated Class I Medical devices
- Recall started
- 20 December 2021
- Terminated
- 28 August 2024
- Reason
- Potential cessation in ventilation can occur under specific conditions.
- 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 and WV, including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0622-2022
- 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 ventilatory support to adult and pediatric p
Terminated Class II Medical devices
- Recall started
- 25 November 2019
- Terminated
- 8 August 2023
- Reason
- The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1439-2020
- bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxyg
Terminated Class I Medical devices
- Recall started
- 13 March 2019
- Terminated
- 22 September 2020
- Reason
- Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- Distribution
- Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, Uni
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1385-2019, Z-1386-2019
- enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
- enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Terminated Class I Medical devices
- Recall started
- 20 June 2018
- Terminated
- 28 July 2020
- Reason
- Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
- Distribution
- Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2826-2018
- The Tri-Flo Subglottic Suction System
Terminated Class I Medical devices
- Recall started
- 8 May 2018
- Terminated
- 7 July 2020
- Reason
- An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
- Distribution
- US distribution only to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2552-2018, Z-2553-2018
- AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K80
- AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pr
Terminated Class I Medical devices
- Recall started
- 27 April 2017
- Terminated
- 9 May 2019
- Reason
- The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
- Distribution
- Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1580-2018, Z-1549-2018, Z-1551-2018, Z-1560-2018, Z-1567-2018, Z-1557-2018, Z-1569-2018, Z-1566-2018, Z-1572-2018, Z-1579-2018, Z-1570-2018, Z-1564-2018 and 23 more
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure vent
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to pat
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide pos
- AirLife Resuscitation, Adult, 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 ve
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provi
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ven
- AirLife Resuscitation, Infant, 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 venti
- and 27 more product lines
Terminated Class I Medical devices
- Recall started
- 29 November 2014
- Terminated
- 5 February 2021
- Reason
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0346-2018, Z-0343-2018, Z-0344-2018, Z-0345-2018
- 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 de
- 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
- 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
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.