Lower risk Medical device recall · FDA · Published January 17, 2019

CryoLife On-X Aortic Heart Valve Mislabeled Serial Number Recall

CryoLife recalls On-X Aortic Heart Valve with incorrect serial number labeling. Affected units have model ONXANE-23, lot 6827216. No immediate action needed as mislabeling does not affect safety.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1073-2019Medical device CryoLife ›

Lower-risk recall

On-X Valve was mislabeled with the incorrect serial number.

Take action

Contact the company

Recalling firmCryoLife, Inc.1655 Roberts Blvd Nw · Kennesaw, GA 30144-3632

✎ GovInfoNow plain-language explainer

CryoLife is recalling On-X Aortic Heart Valves with incorrect serial numbers. This mislabeling does not pose a safety risk to users and does not require immediate action. Read more at govinfonow.com/recall/69106-cryolife-on-x-aortic-heart-valve-mislabeled-serial-number-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/69106-cryolife-on-x-aortic-heart-valve-mislabeled-serial-number-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1073-2019

Cite this page

“CryoLife On-X Aortic Heart Valve Mislabeled Serial Number Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69106-cryolife-on-x-aortic-heart-valve-mislabeled-serial-number-recall. Based on FDA recall #Z-1073-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1073-2019%22&limit=1).

CryoLife, Inc. recalled On-X Aortic Heart Valves with Anatomic Sewing Ring due to mislabeling with incorrect serial numbers, according to the FDA on Jan. 17, 2019.

How to tell if you have it

Brand: CryoLife
Product: On-X Aortic Heart Valve with Anatomic Sewing Ring
Model/Catalog Number: ONXANE - 23
Lot number: 6827216
Expiration Date: 11/19/2024
Quantity: 2 devices

The hazard

The On-X Valve was mislabeled with the incorrect serial number, according to the FDA.

Context

GovInfoNow's records show CryoLife, Inc. has had five other recalls since May 14, 2018. Other recent recalls include a BioGlue Surgical Adhesive issue on Oct. 7, 2021, and an SG Pulmonary Heart Valve recall on Nov. 10, 2020.

How to tell if you have this one

Check if your valve has model ONXANE-23 and lot number 6827216. The product was sold with an expiration date of 11/19/2024.

Brand
CryoLife
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your valve's serial number matches the recalled model ONXANE-23 and lot 6827216.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution - US Nationwide - Georgia and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Jan 17, 2019Firm started the recall
Mar 28, 2019FDA classified it Class II
Apr 3, 2019Published in FDA’s Enforcement Report
Jun 9, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More CryoLife recalls

Link to this recall

<a href="https://govinfonow.com/recall/69106-cryolife-on-x-aortic-heart-valve-mislabeled-serial-number-recall">CryoLife On-X Aortic Heart Valve Mislabeled Serial Number Recall (GovInfoNow)</a>

Where this comes from

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-1073-2019 (January 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1073-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.