Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement 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 Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Quantity: 52
Why Was This Recalled?
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
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