Z-0489-2024Class II

vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency...

Name: Z-0489-2024 vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency...
Creator: Vyaire Medical
Published: 2023-10-27
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2023-10-27 / Completed / root cause: manufacturing process

FDA source

Vyaire Medical began a recall of vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) on 2023-10-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0489-2024
Classification: Class II
Status: Completed
Initiated: 2023-10-27
Posted: 2023-12-05
Recalling firm: Jaeger Medical GmbH
Product: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Product code: LSZ Ventilator, High Frequency
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vyaire issued a Customer Notification to its consignees on 10/27/2023 via email. The notice explained the issue and how to identify the affected products. The firm is seeking the return of the circuits.
Quantity in commerce: 16 circuits
Distribution: US: Florida
Product codes and lots: UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2024	Class II	Completed	Voluntary: Firm initiated	2023-12-13	2023-12-05
Z-0489-2024	Class II	Completed	Voluntary: Firm initiated	2023-12-13	2023-12-05

Product code LSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)