Device recall: vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory…

Class II FDA enforcement event 93332. Recall start date: 27 Oct 2023. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

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 II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Vyaire Medical started this device recall on 27 Oct 2023. The firm address in the FDA record is in Mettawa, IL. FDA put the recall in Class II. FDA event 93332 has 2 product records. The first FDA enforcement report date is 13 Dec 2023. The record gives the status Completed.

FDA enforcement report The 2 product records

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US: Florida

Recalling firm

Vyaire Medical, Mettawa, IL.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 93332: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0488-2024	vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)	188 circuits	Class II	Completed	13 Dec 2023
Z-0489-2024	vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)	16 circuits	Class II	Completed	13 Dec 2023

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Vyaire Medical
Initiated	Product (first record)	Type	Class	Records
10 Apr 2025	Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A P	Device	Class I	2
10 Jan 2024	AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,	Device	Class I	9
5 May 2023	bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator	Device	Class II	2
20 Dec 2021	bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e	Device	Class I	1
25 Nov 2019	bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation	Device	Class II	1
13 Mar 2019	enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.	Device	Class I	2
20 Jun 2018	The Tri-Flo Subglottic Suction System	Device	Class I	1
8 May 2018	AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8	Device	Class I	2
18 Jul 2017	AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2	Device	Class II	1
27 Apr 2017	AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manua	Device	Class I	35

Vyaire Medical: all 12 events

Official channels

FDA enforcement report Z-0488-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 93332. https://recallregister.com/fda/ii/93332/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US: Florida
What quantity of product is in FDA event 93332?: The event has 2 product records. The first record gives this quantity: 188 circuits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.