Recall Register

Vyaire Medical: FDA recalls

FDA enforcement reports name Vyaire Medical as the recalling firm in 12 events. The events have 62 product records. The recalls started from 2014 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

12 events, newest first.

FDA enforcement events of Vyaire Medical
InitiatedProduct (first record)TypeClassRecordsStatus
10 Apr 2025Brand 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 (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.DeviceClass I2Ongoing
10 Jan 2024AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,DeviceClass I9Ongoing
27 Oct 2023vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)DeviceClass II2Completed
5 May 2023bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use VentilatorDeviceClass II2Completed
20 Dec 2021bellavista 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 patients, and optionally, infant and neonatal patients.DeviceClass I1Terminated
25 Nov 2019bellavista 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 oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the…DeviceClass II1Terminated
13 Mar 2019enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.DeviceClass I2Terminated
20 Jun 2018The Tri-Flo Subglottic Suction SystemDeviceClass I1Terminated
8 May 2018AirLife 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 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen…DeviceClass I2Terminated
18 Jul 2017AirLife(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 includes a larger needle (23 Gage, 1" needle),…DeviceClass II1Terminated
27 Apr 2017AirLife Resuscitation, Adult, with mask, oxygen reservoir bag 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 own.DeviceClass I35Terminated
29 Nov 2014Infant 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 gasses to patients requiring invasive and…DeviceClass I4Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Vyaire Medical: events for each product type
TypeEvents
Device12
Vyaire Medical: events in each class
ClassEvents
Class I8
Class II4
Share of the events of the firm in Class I
67%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Vyaire Medical, by the year that the recall started. The largest year is 2017, with 2 events.

Official channels

Cite this page

Recall Register. Vyaire Medical: FDA recalls. https://recallregister.com/firm/vyaire-medical/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Vyaire Medical have?
Class I: 8 events. Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Vyaire Medical?
FDA event 96664, which the firm started on 10 Apr 2025. The first product in the record is: 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 (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.
How many FDA recalls of Vyaire Medical have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.