CryoLife, Inc.

FDA recalling firm · 12 enforcement events · 14 product records · 2013–2021 · GA

CryoLife, Inc. has 12 FDA enforcement events on this register (14 product records) between 2013 and 2021: 12 device; the busiest year was 2018 with 3.

0% of its events are Class I; the most common class is Class II (12). 0 events are listed as ongoing; the recalling firm's address is in GA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
7 Oct 2021	BioGlue Surgical Adhesive, Model BG3510-5-G	Device	Class II	1	Terminated
10 Nov 2020	CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the…	Device	Class II	2	Terminated
17 Jan 2019	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…	Device	Class II	1	Terminated
6 Sep 2018	CryoPatch SG Pulmonary Hemi-Artery, 1 graft	Device	Class II	1	Terminated
4 Jun 2018	BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).	Device	Class II	1	Terminated
14 May 2018	Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO	Device	Class II	2	Terminated
19 May 2017	BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J	Device	Class II	1	Terminated
21 Nov 2016	CryoPatch SG Pulmonary Hemi-Artery Patch	Device	Class II	1	Terminated
12 Jun 2015	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	Device	Class II	1	Terminated
25 Apr 2014	BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).	Device	Class II	1	Terminated
12 Feb 2014	On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.	Device	Class II	1	Terminated
22 Nov 2013	Pulmonary Hemi-Artery SG Used in heart surgery	Device	Class II	1	Terminated

By type and class

Device12

Class II12

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for CryoLife, Inc. by year initiated.

Questions and answers

How many FDA recalls has CryoLife, Inc. had?

12 enforcement events (14 product records) on this register, 2013–2021: 12 device.

Are any CryoLife, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are CryoLife, Inc. recalls?

12 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.