vyaire Flexible Patient Circuit — Class II medical device recall Z-0488-2024
Completed recall by Vyaire Medical, reported 2023-12-13, distributed in FL. Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are onl
| Recall number | Z-0488-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2023-10-27 |
| Classified | 2023-12-05 |
| Reported by FDA | 2023-12-13 |
| Distributed | FL |
| Quantity | 188 circuits |
| UPC / GTIN / UDI-DI | 10190752159747 |
| Serial numbers | 4060467, 4165459, 4167324, 4180598, 4180599, 4180603, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788 and 1 more |
| Model numbers | 29028-003 |
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0488-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.