Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: Recalled by CryoLife, Inc. Due to Mislabeling
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 CryoLife, Inc. directly.
Affected Products
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
Quantity: 2 devices
Why Was This Recalled?
On-X Valve was mislabeled with the incorrect serial number.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CryoLife, Inc.
CryoLife, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report