PlainRecalls

CryoLife, Inc.

Compiled from official public sources by the publisher.

14 recalls on record · Latest: Dec 22, 2021

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Agency notice ledger

Federal filing book CryoLife, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,085 of 14,151 · 14 notices · 0.013% archive

  • BOOK 14 notices
  • RANK #1,085 of 14,151
  • SHARE 0.013% archive
  • AGENCY FDA Devices (14)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 22, 2021
  • PHOTO Actavis Elizabeth LLC

Nearest notice-volume peer: Actavis Elizabeth LLC (0 notice gap)

CryoLife, Inc. accounts for about 0.013% of the 104,423-notice archive on 14 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

CryoLife, Inc.'s standing among 14,151 recalling firms

CryoLife, Inc. ranks 1,085th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

CryoLife, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

14 1085th of 14151 higher than 13,008 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

CryoLife, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows CryoLife, Inc. holds about 0.013% of archive notices alongside 14 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Dec 22, 2021

BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Devices Moderate Dec 30, 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 operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a

FDA Devices Moderate Dec 30, 2020

CryoPatch SG Pulmonary Human Cardiac Patch. The patch 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 patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for
FDA Devices Moderate May 1, 2019

CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Devices Moderate Apr 3, 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 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, siz
FDA Devices Moderate Oct 24, 2018

CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Devices Moderate Aug 1, 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).
FDA Devices Moderate Jun 27, 2018

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
FDA Devices Moderate Jun 27, 2018

Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
FDA Devices Moderate Sep 13, 2017

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.
FDA Devices Moderate Jul 19, 2017

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
FDA Devices Moderate Jul 5, 2017

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
FDA Devices Moderate Jun 11, 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).
FDA Devices Moderate Jan 29, 2014

Pulmonary Hemi-Artery SG Used in heart surgery

CryoLife, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (14 here — thin-book).

Actavis Elizabeth LLC 14 Albertsons Companies, Inc. 14 Allergan Sales, LLC 14 American Contract Systems 14 Aurolife Pharma, LLC 14

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

American Contract Systems 14 Bd Switzerland Sarl 14 Biomet Spine, LLC 14 Cardiac Assist, Inc 14

Frequently Asked Questions

How many federal recall notices name CryoLife, Inc.? ▼
PlainRecalls indexes 14 distinct federal recall events naming CryoLife, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does CryoLife, Inc. sit among other recalling firms? ▼
CryoLife, Inc. ranks #1,085 of 14,151 by distinct recall-event count among 14,151 firms in this archive (92nd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of CryoLife, Inc.'s notices? ▼
FDA Devices accounts for 14 of this firm's 14 indexed notices.
What product category dominates CryoLife, Inc.'s filing book? ▼
Filings for CryoLife, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
CryoLife, Inc.: 14 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming CryoLife, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026