Cryolife recalls
Cryolife appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2021-12-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2014-01-29 to 2021-12-22 |
| By agency | FDA Device (14) |
| By classification | Class II (14) |
| By status | terminated (14) |
| Distribution named in notices | AR, CA, IL, OH, TX, US |
Recalls
- BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Device · Class II · 2021-12-22 · Cryolife
Reason: Product is not approved for use in the EU and should not have been distributed in the EU. - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife
Reason: On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjec… - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife
Reason: On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjec… - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife
Reason: The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife
Reason: On-X Valve was mislabeled with the incorrect serial number. - CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Device · Class II · 2018-10-24 · Cryolife
Reason: The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. - BioGlue Spreader Tip, 12mm, Sterile, RX Only
FDA Device · Class II · 2018-08-01 · Cryolife
Reason: The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes. - Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
FDA Device · Class II · 2018-06-27 · Cryolife
Reason: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. - Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
FDA Device · Class II · 2018-06-27 · Cryolife
Reason: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. - On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use
FDA Device · Class II · 2017-09-13 · Cryolife
Reason: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. - On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart…
FDA Device · Class II · 2017-07-19 · Cryolife
Reason: Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring. - BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
FDA Device · Class II · 2017-07-05 · Cryolife
Reason: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. - BG3515-5 US 5mL BioGlue Surgical Adhesive
FDA Device · Class II · 2014-06-11 · Cryolife
Reason: Serum albumin component monomer failed to meet internally established end of shelf-life specification. - Pulmonary Hemi-Artery SG Used in heart surgery
FDA Device · Class II · 2014-01-29 · Cryolife
Reason: Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.