CLASS II Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

vyaire Flexible Patient Circuit, 3100A recalled by Vyaire Medical

Vyaire Medical is recalling vyaire Flexible Patient Circuit, 3100A, distributed in Florida. The recall was initiated on 27 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/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

Quantity recalled188 circuits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0488-2024
FDA event ID: 93332
Recalling firm: Vyaire Medical, Mettawa, IL
Classification: Class II
Status: Completed
Recall initiated: 27 Oct 2023
FDA classified: 5 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

27 Oct 2023	Recall initiated by company
5 Dec 2023	Classified by FDA	+39 days
13 Dec 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Where it was distributed

US: Florida

Florida

Questions about this recall

Is vyaire Flexible Patient Circuit, 3100A recalled?

Yes. Vyaire Medical recalled vyaire Flexible Patient Circuit, 3100A on 27 Oct 2023. The recall is Class II and its status is Completed. Recall number Z-0488-2024.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

US: Florida

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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