Cryolife Inc CryoValve, Pulmonary Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve & Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #40658, Serial #6547591, Model #PV00* Donor #40914, Serial #6565514, Model #PV00* Donor #52097, Serial #7082478, Model #PV00* Donor #52100, Serial #7085341, Model #PV00* Donor #52647, Serial #7075544, Model #PV00* Donor #54259, Serial #7284361, Model #PV00
Products Sold
Donor #40658, Serial #6547591, Model #PV00* Donor #40914, Serial #6565514, Model #PV00* Donor #52097, Serial #7082478, Model #PV00* Donor #52100, Serial #7085341, Model #PV00* Donor #52647, Serial #7075544, Model #PV00* Donor #54259, Serial #7284361, Model #PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve & Conduit due to During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
Recommended Action
Per FDA guidance
Consignees were notified by letter dated May 6, May 11, or May 12, 2004.
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 noticeDistribution
As reported by FDA
FL, NE, NV, NY, NC, TN, TX, UT, WA
Page updated: Jan 10, 2026