CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

On-X Prosthetic Heart Valve recalled by CryoLife

CryoLife is recalling On-X Prosthetic Heart Valve, distributed nationwide in the US. The recall was initiated on 12 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908

Quantity recalled52

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-2715-2017
FDA event ID: 77565
Recalling firm: CryoLife, Kennesaw, GA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jun 2015
FDA classified: 11 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

12 Jun 2015	Recall initiated by company
11 Jul 2017	Classified by FDA	+760 days
19 Jul 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel

Nationwide Alabama California Florida Iowa Indiana Louisiana Massachusetts Minnesota Missouri Mississippi North Carolina Oregon Pennsylvania Tennessee

Questions about this recall

Is On-X Prosthetic Heart Valve recalled?

Yes. CryoLife recalled On-X Prosthetic Heart Valve on 12 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2715-2017.

Why was it recalled?

Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.

Which lots are affected?

Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908

Where was it sold?

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel

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 21 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
22 Dec 2021Device	CLASS II	BioGlue Surgical Adhesive recalled by CryoLife	CryoLife	Hidden Drug Ingredients	GA
30 Dec 2020Device	CLASS II	CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife	CryoLife	Sterility	Nationwide
30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Sterility	Nationwide
1 May 2019Device	CLASS II	CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife	CryoLife	Other	TX
3 Apr 2019Device	CLASS II	On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife	CryoLife	Labeling Errors	Nationwide

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