Vyaire Medical: Medical Device Recall in 2023 - (Recall #: Z-0488-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Product Classification:

Class II

Date Initiated: October 27, 2023

Date Posted: December 13, 2023

Recall Number: Z-0488-2024

Event ID: 93332

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.

Status: Completed

Product Quantity: 188 circuits

Code Information:

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

Distribution Pattern:

US: Florida

Voluntary or Mandated:

Voluntary: Firm initiated