Flexible Patient Circuit (Vyaire) – unapproved distribution (2023)
Unauthorized medical device distribution can potentially cause regulatory compliance issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Brand
Vyaire Medical
Lot Codes / Batch 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
Products Sold
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
Vyaire Medical is recalling vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequ due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026