On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2715-2017.
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2715-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Cryolife, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2715-2017.
CryoLife, Inc.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Cryolife, Inc. Recall FAQ
Cryolife, Inc. is the subject of a medical implants safety report: On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic.... The notice was published on June 12, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 52 units are potentially affected.