On-X Prosthetic Heart Valve Product Usage: Indicated for the… — Class II medical device recall Z-2715-2017
Terminated recall by CryoLife, Inc., reported 2017-07-19, distributed nationwide. Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an
| Recall number | Z-2715-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2015-06-12 |
| Classified | 2017-07-11 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2020-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI, GB, IL |
| Quantity | 52 |
| Reason classes | labeling |
| Serial numbers | 4001123, 4237725, 4508717, 4508804, 4508807, 4520208, 4520709, 4520711, 4520719, 4525415, 4525417, 458719, 4587605, 4587712, 4616112, 4616313, 4622025, 4622126, 4622210, 4622225, 4622315, 4632012, 4632013, 4671765, 4712108 and 26 more |
Product
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Reason for recall
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
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-2715-2017. 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.