CryoLife, Inc. recalls
Every recall we track for CryoLife, Inc. — 8 in all, from 2018–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from CryoLife, Inc. peaked in 2018 (4); 8 since 2017.
All FDA recall records for CryoLife, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 2 | 4 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 1 | 1 | 2 |
| 2021 | 0 | 0 | 0 | 1 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled CryoLife, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All CryoLife, Inc. recalls
6 shown- UnratedMedical device
CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G
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.
CryoLifeOct 7, 2021 - UnratedMedical device
CryoLife, Inc. recalls CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing
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.
CryoLifeNov 10, 2020 - Lower riskMedical device
CryoLife, Inc. recalls On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the
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.
CryoLifeJan 17, 2019 - Lower riskMedical device
CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery, 1 graft
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.
CryoLifeSep 6, 2018 - Lower riskMedical device
CryoLife, Inc. recalls BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard
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.
CryoLifeJun 4, 2018 - UnratedMedical device
CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
CryoLife recalls Cryovalve SG Pulmonary Heart Valve (Catalog SGPVVOO) after autopsy reports found morphine in patient urine. This may indicate improper use or contamination.
CryoLifeMay 14, 2018
CryoLife, Inc. recall questions
How many recalls has CryoLife, Inc. had?
8 recalls from CryoLife, Inc. are on record with U.S. safety agencies, from 2018–2021.
What is the most recent CryoLife, Inc. recall?
CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G, dated Oct 7, 2021. Every CryoLife, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled CryoLife, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new CryoLife, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.