Cryolife Inc CryoValve Heart Valve Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Heart Valve
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donors processed prior to 1/26/1998
Products Sold
Donors processed prior to 1/26/1998
Cryolife Inc is recalling CryoValve Heart Valve due to CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for cert. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
Recommended Action
Per FDA guidance
Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026