Cryovalve — Class II medical device recall Z-2271-2018
Terminated recall by CryoLife, Inc., reported 2018-06-27, distributed in AR, OH. Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports i
| Recall number | Z-2271-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2018-05-14 |
| Classified | 2018-06-21 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2019-03-29 |
| Distributed | AR, OH |
| Quantity | 1 units |
| Serial numbers | 10988203 |
Product
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Reason for recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2271-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.