UnratedMedical device recall · FDA · Published November 10, 2020
CryoLife SG Pulmonary Heart Valve Recall: Microbial Test Failures
CryoLife recalls SG Pulmonary Heart Valves with microbial culture test failures in processing. Affected units have specific serial numbers and UDI codes. Consumers should contact CryoLife for details.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
Take action
Contact the company
📍Recalling firmCryoLife, Inc.1655 Roberts Blvd Nw · Kennesaw, GA 30144-3632
“CryoLife SG Pulmonary Heart Valve Recall: Microbial Test Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63946-cryolife-sg-pulmonary-heart-valve-recall-microbial-test-failures. Based on FDA recall #Z-0652-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0652-2021%22&limit=1).
The FDA announced on November 10, 2020, that CryoLife, Inc. is recalling CryoValve SG Pulmonary Human Heart Valves due to post-processing microbial culture test failures. The agency said the issue involves a TRIS saline solution lot used in processing other allografts.
How to tell if you have it
Brand: CryoLife
Product: CryoValve SG Pulmonary Human Heart Valve
Model/Catalog Number: SGPV00
Serial Numbers: 11685214, 11685554, and 11682491
UDI: 00877234000447
Quantity: 3 units
Distribution: Nationwide to GA, AZ, TX, MO, and OK
The hazard
The FDA said the recall addresses post-processing microbial culture test failures for allografts processed using a specific TRIS saline solution lot. The agency reported that this same lot was used in processing other allografts subjected to the recall.
Context
GovInfoNow's records show CryoLife, Inc. has 5 other recalls on record since May 14, 2018. Other recent recalls of similar products include On-X Mitral Heart Valve Recall (February 1, 2026), Getinge Thoracic Catheter Recall (August 7, 2026), and Medline Heart Cath Pack-LF Kits Recall (March 24, 2026).
How to tell if you have this one
Check for serial numbers 11685214, 11685554, or 11682491 on the packaging. The unique device identifier (UDI) 00877234000447 also identifies affected units.
Brand
CryoLife
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distributed nationwide to GA, AZ, TX, MO, and OK.
Recall number
Product, codes & lots
Quantity
Z-0652-2021
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.; Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447
3 units
Z-0653-2021
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.; Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485
2 units
Based on the official FDA remedy
What to do — step by step
Contact CryoLife
Reach out to CryoLife directly to confirm if your valve is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Distributed nationwide to GA, AZ, TX, MO, and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Georgia, Missouri, Oklahoma, Texas.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0652-2021 (November 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0652-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.