Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
vyaire Flexible Patient Circuit Recalled by Vyaire Medical Due to Two patient circuits, 29028-003 and 29028-004, for the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vyaire Medical directly.
Affected Products
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Quantity: 188 circuits
Why Was This Recalled?
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.
Where Was This Sold?
US: Florida
About Vyaire Medical
Vyaire Medical has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report