CryoLife, Inc. recalls

12 recalls on record · latest: October 7, 2021

Official U.S. recall history for CryoLife, Inc., compiled from official government records.

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CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G

October 7, 2021 · Medical device recalls Moderate risk Product is not approved for use in the EU and should not have been distributed…

CryoLife, Inc. recalls CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotecta…

November 10, 2020 · Medical device recalls Moderate risk On November 10, 2020, it was discovered that there are post- processing microbi…

CryoLife, Inc. recalls CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotec…

November 10, 2020 · Medical device recalls Moderate risk On November 10, 2020, it was discovered that there are post- processing microbi…

CryoLife product recalled over labeling errors

January 17, 2019 · Medical device recalls Moderate risk On-X Valve was mislabeled with the incorrect serial number.

CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery, 1 graft

September 6, 2018 · Medical device recalls Moderate risk The conduit length and branch length of a SG Pulmonary Hemi-Artery were switche…

CryoLife, Inc. recalls BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard met…

June 4, 2018 · Medical device recalls Moderate risk The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x…

CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

May 14, 2018 · Medical device recalls Moderate risk Devices, which met FDA and AATB eligibility criteria, were distributed. Final a…

CryoLife, Inc. recalls Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020

May 14, 2018 · Medical device recalls Moderate risk Devices, which met FDA and AATB eligibility criteria, were distributed. Final a…

CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

May 19, 2017 · Medical device recalls Moderate risk The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX…

CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery Patch

November 21, 2016 · Medical device recalls Moderate risk The device is recalled due to donor ineligibility of released human tissue. The…

CryoLife product recalled over labeling errors

June 12, 2015 · Medical device recalls Moderate risk Incorrect product label. The type of Sewing Ring was mislabeled as being a Stan…

CryoLife, Inc. recalls On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damage…

February 12, 2014 · Medical device recalls Moderate risk Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistribute…