FDA Medical Device Recalls (openFDA)
Vyaire Medical: vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Recall number
- Z-0488-2024
- Recalling firm
- Vyaire Medical
- Product
- vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Status
- Completed
- Initiated
- 2023-10-27
- Posted
- 2023-12-05
- Terminated
- not on file
- 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.
- 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
- 188 circuits
- Distribution
- US: Florida
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P890057"]
- Product code
- LSZ
- Firm FEI
- 3013421741
- Firm city
- Mettawa
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28