CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife
CryoLife is recalling On-X Aortic Heart Valve with Anatomic Sewing Ring, distributed nationwide in the US. The recall was initiated on 17 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1073-2019
- FDA event ID
- 82044
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jan 2019
- FDA classified
- 28 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jan 2019 | Recall initiated by company | |
| 28 Mar 2019 | Classified by FDA | +70 days |
| 3 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
On-X Valve was mislabeled with the incorrect serial number.
Product as listed by the FDA
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
Where it was distributed
Worldwide Distribution - US Nationwide - Georgia and Germany.
Questions about this recall
Why was it recalled?
On-X Valve was mislabeled with the incorrect serial number.
Which lots are affected?
Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024
Where was it sold?
Worldwide Distribution - US Nationwide - Georgia and Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CryoLife
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioGlue Surgical Adhesive recalled by CryoLife | CryoLife | Hidden Drug Ingredients | GA |
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife | CryoLife | Other | TX |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery, 1 graft recalled by CryoLife | CryoLife | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |