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Sign in to claim this brandVYAIRE MEDICAL, INC.
United States·US-MF-000008254
Last updated September 17, 2026
What VYAIRE MEDICAL, INC. makes
Vyaire Medical produces single-use breathing circuits for ventilators and anaesthesia, including straight and elbow connectors, as well as benchtop nebulizers for delivering therapeutic agents. Their portfolio includes neonatal and adult intensive-care ventilators, nasal oxygen cannulas, and respiratory oxygen therapy systems like face masks. Devices such as the LTV, Vmax, and 3100B HFOV are designed for controlled ventilation and oxygen delivery in critical care settings.
The company’s devices are classified under FDA’s Class I, II, III, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vyaire Medical, Inc. manufacture?
Vyaire Medical, Inc. specializes in devices primarily used in critical care and respiratory therapy. Their portfolio includes single-use breathing circuits for ventilators and anaesthesia, such as straight and elbow connectors, as well as benchtop nebulizers for delivering therapeutic agents. They also produce neonatal and adult intensive-care ventilators, nasal oxygen cannulas, and respiratory oxygen therapy systems like face masks. These devices are designed to support controlled ventilation and oxygen delivery in clinical settings.
Where is Vyaire Medical, Inc. based, and what does that mean for their regulatory oversight?
Vyaire Medical, Inc. is based in the United States, which means their devices fall under the regulatory jurisdiction of the FDA. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking for these devices. The U.S. location also influences classification and reporting requirements under FDA regulations.
How are Vyaire Medical’s devices classified under FDA regulations?
Vyaire Medical’s devices are classified across multiple FDA categories: Class I (generally low-risk), Class II (moderate risk with special controls), Class III (high-risk requiring premarket approval), and Unclassified (U) devices. The classification depends on factors like the device’s purpose, risk level, and intended use—for example, ventilators like the Vmax or 3100B HFOV are typically Class III due to their critical role in patient care, while single-use connectors may fall into Class I or II. Classification determines the regulatory pathway and scrutiny required for each device.
Which regulatory registries or databases list Vyaire Medical’s devices?
Vyaire Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling transparent tracking, traceability, and compliance monitoring. This registry helps healthcare providers, regulators, and other stakeholders verify device details, including specifications and regulatory status, ensuring proper use and safety in clinical environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 26125, N Riverwoods Blvd, Mettawa, United States
- Website
- vyaire.com
- —
- —
- [email protected]
- Phone
- +1 872 757 0085
- PRRC Contact
- Mindy Faber
- EUDAMED SRN
- US-MF-000008254
- FDA FEI Number
- 3013421741
- DUNS Number
- 080456871
Catalogue (677)
Page 14 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vmax | 776269 | FDA UDI | Class II | Active |
| Ltv | 10700 | FDA UDI | Class II | Active |
| Avea™ | 7003100 | FDA UDI | Class II | Unknown |
| Avea | 16179 | FDA UDI | Class II | Active |
| Vital Signs™ | AFNX80X4F | FDA UDI | Class I | Active |
| Vmax | 777407-103 | FDA UDI | Class II | Active |
| 3100 Hfov | 26209-001 | FDA UDI | Class III | Active |
| Bird™ | 10011A | FDA UDI | Class II | Active |
| Avea | 769734 | FDA UDI | Class II | Active |
| FreeFlow™ | 773470 | FDA UDI | Class II | Active |
| 3100a Hfov | 29028-021 | FDA UDI | Class III | Unknown |
| Blender | 03803T | FDA UDI | Class II | Active |
| Avea™ | 11732 | FDA UDI | Class II | Unknown |
| Infant Flow™ | 777024 | FDA UDI | Class II | Active |
| Infant Flow™ | 777040S | FDA UDI | Class II | Active |
| Multi-Link X2 ECG Cable and Leadwire System | K211294 | FDA 510(k) | Class II | Active |
| Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | K181524 | FDA 510(k) | Class II | Active |
| Multi-Link X2 ECG and SpO2 Adapter | K191273 | FDA 510(k) | Class II | Active |
| AirLife DuoTherm™ Humidification System | K231380 | FDA 510(k) | Class II | Active |
| Vyntus/SentrySuite Product Line | K183567 | FDA 510(k) | Class II | Active |
| Vyntus BODY | K190853 | FDA 510(k) | Class II | Active |
| AirLife Adult Heated Wire BiPAP/NIV Circuit | K170378 | FDA 510(k) | Class II | Active |
| AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | K230915 | FDA 510(k) | Class II | Active |
| Multi-LinkTM X2 ECG Adapter and Leadwires | K200510 | FDA 510(k) | Class II | Active |
| LTV2 Series Ventilators | K201082 | FDA 510(k) | Class II | Active |
| AirLife DuoTherm™ | 377HTR220 | EUDAMED | Class IIb | Active |
| Diagnostics Package Capnography Mainstream | 301.114.000 | EUDAMEDFDA UDI | Class IIb | Active |
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FDA Recalls (62)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Vyaire Medical, Inc. has initiated 62 recall records between November 29, 2014, and April 10, 2025, with statuses including completed, open, classified, and terminated. The recalls involve issues such as mask disconnection risks, incorrect sub-assemblies in ABG sampling kits, touchscreen unresponsiveness in ventilators, unauthorized distribution of non-U.S.-approved patient circuits, adapter disconnections, humidification chamber overfill, ventilation cessation, aluminum elution from disposable cartridges, airflow obstruction in resuscitation devices, and potential catheter breakage in suction systems. Reasons cited include design flaws, manufacturing errors, and distribution missteps as documented in the records.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 10, 2025 | Z-1697-2025 | — | open, classified | 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. |
| Apr 10, 2025 | Z-1698-2025 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1060-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1059-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1058-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1061-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1064-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1062-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1063-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1057-2024 | — | open, classified | 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. |
| Jan 10, 2024 | Z-1065-2024 | — | open, classified | 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. |
| Oct 27, 2023 | Z-0488-2024 | — | completed | 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. |
| Oct 27, 2023 | Z-0489-2024 | — | completed | 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. |
| May 5, 2023 | Z-1967-2023 | — | completed | 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. |
| May 5, 2023 | Z-1966-2023 | — | completed | 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. |
| Dec 20, 2021 | Z-0622-2022 | — | terminated | Potential cessation in ventilation can occur under specific conditions. |
| Nov 25, 2019 | Z-1439-2020 | — | terminated | 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. |
| Mar 13, 2019 | Z-1385-2019 | — | terminated | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Mar 13, 2019 | Z-1386-2019 | — | terminated | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Jun 20, 2018 | Z-2826-2018 | — | terminated | 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. |
| May 8, 2018 | Z-2553-2018 | — | terminated | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. |
| May 8, 2018 | Z-2552-2018 | — | terminated | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. |
| Jul 18, 2017 | Z-3080-2017 | — | terminated | Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit. |
| Apr 27, 2017 | Z-1570-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1548-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1576-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1571-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1547-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1578-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1554-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1564-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1580-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1556-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1565-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1579-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1574-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1573-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1572-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1560-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1555-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1562-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1563-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1567-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1581-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1568-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1561-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1566-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1551-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1550-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1552-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1559-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1577-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1549-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1558-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1575-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1557-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1569-2018 | — | terminated | 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. |
| Apr 27, 2017 | Z-1553-2018 | — | terminated | 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. |
| Nov 29, 2014 | Z-0343-2018 | — | terminated | 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. |
| Nov 29, 2014 | Z-0344-2018 | — | terminated | 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. |
| Nov 29, 2014 | Z-0345-2018 | — | terminated | 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. |
| Nov 29, 2014 | Z-0346-2018 | — | terminated | 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. |