Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 30, 2020
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
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 a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
CryoLife, Inc. recalled CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture… - a moderate-severity action.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture… was recalled by CryoLife, Inc. in December 30, 2020. Reason: On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for o…. Check the official notice for the remedy. Verify recall #Z-0652-2021 with the FDA Devices before acting.
The recall
CryoLife, Inc. issued this moderate-severity FDA Devices recall-On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for o….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- December 30, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0652-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0652-2021) was formally reported on December 30, 2020, with the manufacturer initiating the action on November 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. CryoLife, Inc. is listed as the recalling firm, operating out of Kennesaw, GA. Federal records list the affected scope as 3 units.
The documented reason for this recall is: 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 subjec… Distribution data in the federal record shows the product reached: Distributed nationwide to GA, AZ, TX, MO, and OK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0652-2021 |
| Date reported | December 30, 2020 |
| Date initiated | November 10, 2020 |
| Recalling firm | CryoLife, Inc. |
| Firm location | Kennesaw, GA |
| Affected scope | 3 units |
| Distribution | Distributed nationwide to GA, AZ, TX, MO, and OK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0652-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CryoLife, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0652-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide to GA, AZ, TX, MO, and OK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0652-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 30, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.