Manufacturer
14 recalls in our database name CryoLife, Inc. as the manufacturing or recalling firm.
Of the 14 recalls from CryoLife, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.
CryoLife is recalling a pulmonary hemi-artery patch because the tissue donor tested positive for Enterobacter cloacae.
CryoLife, Inc. is recalling two On-X Aortic Heart Valves because they were mislabeled with incorrect serial numbers. The devices were distributed in Georgia and Germany.
CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.
CryoLife, Inc. is recalling BioGlue Spreader Tips because incorrect labels were applied to the packaging, and some required components were missing from the boxes.
CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
CryoLife is recalling five On-X Prosthetic Heart Valves because a return authorization error caused them to be redistributed and implanted in two patients.
CryoLife, Inc. is recalling 52 On-X Prosthetic Heart Valves because the sewing ring type was mislabeled as Standard instead of Anatomic.
CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.
CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.
CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
CryoLife
Medical device company
Source: Wikidata (Q5190505), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.