Lower risk Medical device recall · FDA · Published October 27, 2023

Vyaire Flexible Patient Circuit 3100A Recall: Non-U.S. Approved Circuits Distributed

Vyaire Medical recalls 3100A Flexible Patient Circuits with serial numbers 4022993-4253792 that were distributed in the U.S. despite being approved only for non-U.S. use. This poses a risk of improper use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0489-2024Medical device Vyaire Medical ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420

✎ GovInfoNow plain-language explainer

Vyaire Medical is recalling specific flexible patient circuits for their 3100A ventilator that were distributed in the U.S. even though they were only approved for use outside the country. This could lead to improper use if used in the U.S. without proper approval. Read more at govinfonow.com/recall/56994-vyaire-flexible-patient-circuit-3100a-recall-non-u-s-approved.

Source Summary by GovInfoNow · govinfonow.com/recall/56994-vyaire-flexible-patient-circuit-3100a-recall-non-u-s-approved · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0489-2024

Cite this page

“Vyaire Flexible Patient Circuit 3100A Recall: Non-U.S. Approved Circuits Distributed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56994-vyaire-flexible-patient-circuit-3100a-recall-non-u-s-approved. Based on FDA recall #Z-0489-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2024%22&limit=1).

Vyaire Medical voluntarily recalled the vyaire Flexible Patient Circuit, REF 29028-004, distributed in Florida. The Food and Drug Administration announced the Class II recall on Oct. 27, 2023, because the circuits were intended for use outside the U.S.

How to tell if you have it

Brand: Vyaire Medical
Product: vyaire Flexible Patient Circuit, 3100A
REF: 29028-004
UDI/DI: 10190752155251
Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
Distribution: Florida

The hazard

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.

Context

GovInfoNow's records show Vyaire Medical has 9 other recalls on record since July 18, 2017. Other recent recalls of similar products include the AirLife Infant Heated Wire Circuit Recall (April 10, 2025), the Vyaire AirLife Adult Resuscitator Recall (Jan. 10, 2024), and the Vyaire Medical Bellavista 1000 Ventilator Recall (May 5, 2023). Other recent recalls of similar products include the MicroPort HIPTURN Fem Head Trial 36mm Recalled (Dec. 19, 2025), the Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), and the Vantive US Healthcare Prismaflex HF1000 Set Recall (Jan. 6, 2026).

How to tell if you have this one

Check for the serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792. The circuits are intended for the 3100A High Frequency Oscillatory Ventilator.

Brand
Vyaire Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
Distribution
US: Florida

Recall number	Product, codes & lots	Quantity
Z-0488-2024	vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV); UDI/DI 10190752159747: Lot/serial numbers: 4060467, 4165459, 4167324, 4180598, 4180599, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788, 4253789, 4180603	188 circuits
Z-0489-2024	vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV); UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792	16 circuits

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for the serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792.

Where it went and when

Where it was distributed

Distributed in Florida.

FDA distribution: “US: Florida” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA published this recall 47 days after the firm started it.

Oct 27, 2023Firm started the recall
Dec 5, 2023FDA classified it Class II
Dec 13, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56994-vyaire-flexible-patient-circuit-3100a-recall-non-u-s-approved">Vyaire Flexible Patient Circuit 3100A Recall: Non-U.S. Approved Circuits Distributed (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0489-2024 (October 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0489-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.