Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cryovalve(R) SG Pulmonary Human Heart Valve Recalled by CryoLife, Inc. Due to Devices, which met FDA and AATB eligibility criteria,...
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
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Quantity: 1 unit
Why Was This Recalled?
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Where Was This Sold?
This product was distributed to 2 states: AR, OH
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