CryoLife recalls

CryoLife has 14 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 22 Dec 2021.

Total recalls14since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 22 Dec 2021

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 14 100%Class III 0 0%

Why cryolife is recalled

Product types

By year

202117%
2020214%
2019214%
2018429%
2017321%
2014214%

All cryolife recalls, newest first

14 total

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	Device Malfunction	Nationwide
30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Device Malfunction	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
24 Oct 2018Device	CLASS II	CryoPatch SG Pulmonary Hemi-Artery, 1 graft recalled by CryoLife	CryoLife	Other	Nationwide
1 Aug 2018Device	CLASS II	BioGlue Spreader Tip, Sterile recalled by CryoLife	CryoLife	Other	GA
27 Jun 2018Device	CLASS II	Cryopatch SG Pulmonary Human Cardiac Branch recalled by CryoLife	CryoLife	Other	AR, OH
27 Jun 2018Device	CLASS II	Cryovalve(R) SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Other	AR, OH
13 Sep 2017Device	CLASS II	On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use recalled	CryoLife	Packaging Defects	IL
19 Jul 2017Device	CLASS II	On-X Prosthetic Heart Valve recalled by CryoLife	CryoLife	Labeling Errors	Nationwide
5 Jul 2017Device	CLASS II	BioGlue Surgical Adhesive recalled by CryoLife	CryoLife	Labeling Errors	GA
11 Jun 2014Device	CLASS II	BG3515-5 US BioGlue Surgical Adhesive recalled by CryoLife	CryoLife	Other	Nationwide
29 Jan 2014Device	CLASS II	Pulmonary Hemi-Artery SG Used in heart surgery recalled by CryoLife	CryoLife	Other	CA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.