FDA Device recall Z-0489-2024
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- FDA Device
- Class II
- completed
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) by Vyaire Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-10-27 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vyaire Medical |
| Distribution | FL |
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Reason
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.
Identifiers
| code_info | UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.