Every recall we track for CryoLife, Inc. — 8 in all — plus the complaints and injury reports the public filed about them.
CryoLife recalls BioGlue surgical adhesive model BG3510-5-G for EU distribution. Product not approved for EU use and should not have been sold there.
CryoLife recalls CryoPatch SG Pulmonary Cardiac Patches due to microbial culture test failures in some batches. Affected units have specific model numbers and serials. Consumers should contact CryoLife for details.
CryoLife recalls SG Pulmonary Heart Valves with microbial culture test failures in processing. Affected units have specific serial numbers and UDI codes. Consumers should contact CryoLife for details.
CryoLife recalls On-X Aortic Heart Valve with incorrect serial number labeling. Affected units have model ONXANE-23, lot 6827216. No immediate action needed as mislabeling does not affect safety.
CryoLife recalls SG Pulmonary Hemi-Artery grafts with incorrect labeling of conduit and branch lengths. This labeling error may cause improper use during medical procedures.
CryoLife recalls BioGlue Spreader Tips due to missing Syringe Spreader Tip pouches in packaging. Affected units have model BG3510-5-J and lot 18MJX002. Consumers should check packaging for indicator label.
CryoLife recalls Cryopatch SG Pulmonary Human Cardiac Branch (SGP020) after autopsy reports found morphine in urine. Affected units have specific serial numbers.
CryoLife recalls Cryovalve SG Pulmonary Heart Valve (Catalog SGPVVOO) after autopsy reports found morphine in patient urine. This may indicate improper use or contamination.
