Recall Register

CryoLife, Inc.: FDA recalls

FDA enforcement events from 2013 to 2021; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name CryoLife, Inc. as the recalling firm in 12 events. The events have 14 product records. The recalls started from 2013 to 2021. All the events are device recalls. By FDA enforcement events, CryoLife, Inc. is number 291 of 1,628 firms that have a page. Events that CryoLife, Inc. started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

12 events, newest first.

FDA enforcement events of CryoLife, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
7 Oct 2021BioGlue Surgical Adhesive, Model BG3510-5-GDeviceClass II1Terminated
10 Nov 2020CryoValve 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…DeviceClass II2Terminated
17 Jan 2019On-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…DeviceClass II1Terminated
6 Sep 2018CryoPatch SG Pulmonary Hemi-Artery, 1 graftDeviceClass II1Terminated
4 Jun 2018BioGlue 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).DeviceClass II1Terminated
14 May 2018Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOODeviceClass II2Terminated
19 May 2017BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-JDeviceClass II1Terminated
21 Nov 2016CryoPatch SG Pulmonary Hemi-Artery PatchDeviceClass II1Terminated
12 Jun 2015On-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 positionsDeviceClass II1Terminated
25 Apr 2014BG3515-5 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).DeviceClass II1Terminated
12 Feb 2014On-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.DeviceClass II1Terminated
22 Nov 2013Pulmonary Hemi-Artery SG Used in heart surgeryDeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

CryoLife, Inc.: events for each product type
TypeEvents
Device12
CryoLife, Inc.: events in each class
ClassEvents
Class II12
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of CryoLife, Inc., by the year that the recall started. The largest year is 2018, with 3 events.

Official channels

Cite this page

Recall Register. CryoLife, Inc.: FDA recalls. https://recallregister.com/firm/cryolife-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
GA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of CryoLife, Inc. have?
Class II: 12 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of CryoLife, Inc.?
FDA event 88929, which the firm started on 7 Oct 2021. The first product in the record is: BioGlue Surgical Adhesive, Model BG3510-5-G
How many FDA recalls of CryoLife, Inc. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.