vyaire Flexible Patient Circuit, 3100A, REF 29028-003… recallZ-0488-2024 · Vyaire Medical · initiated Oct 27, 2023
Class II Completed All recalls posted in December 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vyaire Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0488-2024
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Oct 27, 2023
- Posted by the FDA
- Dec 5, 2023
- Recalling firm
- Vyaire Medical
- Quantity
- 188 circuits
- Product code
- LSZ
- FDA submissions
- P890057
- Distribution
- US: Florida
Product description
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
11 devices cleared under P890057 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 3100A HFOV 768901Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY30 reports
- 3100A HFOV 29028-011Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY9 reports
- 3100A HFOV 29028-004Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY6 reports
- 3100A HFOV 29028-003Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY6 reports
- 3100B HFOV 770155Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY4 reports
- 3100A/B 22151-801Carefusion Corporation · Ventilator, High Frequency2 reports
- 3100A HFOV 768901-RFBVyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 11518-850SVyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY1 report
- 3100B HFOV 11744-850KVyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 771465Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY1 report
- 3100A HFOV 29028-012Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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