Vyaire Medical: Medical Device Recall in 2023 - (Recall #: Z-0489-2024)

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 29028-004, 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-0489-2024

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: 16 circuits

Code Information:

UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792

Distribution Pattern:

US: Florida

Voluntary or Mandated:

Voluntary: Firm initiated