---
title: "vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi... — FDA record Z-0489-2024 | Is It on Recall"
description: "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 distribut"
url: https://isitonrecall.com/recall/fda-device-z-0489-2024-vyaire-flexible-patient-circuit-3100a-ref-29028-004-intended-to-be-used-with-the-3100a-high-frequenc/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory ... — FDA record Z-0489-2024

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- **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.
- **Classification**: Class II
- **Recalling firm**: Vyaire Medical
- **Quantity**: 16 circuits
- **Agency-reported status**: Completed
- **Source record identifier**: Z-0489-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: Florida

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)

## Dates in the source

- **Report date**: Dec 13, 2023
- **Recall initiation date**: Oct 27, 2023
- **Center classification date**: Dec 5, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Vyaire Medical records](https://isitonrecall.com/brand/vyaire-medical/)