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.
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.
Take action
Contact the company
📍Recalling firmCryoLife, Inc.1655 Roberts Blvd Nw · Kennesaw, GA 30144-3632
“CryoLife CryoPatch SG Pulmonary Hemi-Artery Recall: Labeling Error.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69904-cryolife-cryopatch-sg-pulmonary-hemi-artery-recall-labeling-error. Based on FDA recall #Z-0121-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0121-2019%22&limit=1).
The FDA announced on Sept. 6, 2018, that CryoLife, Inc. voluntarily recalled its CryoPatch SG Pulmonary Hemi-Artery grafts because product labeling incorrectly switched the conduit and branch lengths. The agency classified this as a Class II recall.
The conduit length and branch length of the 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.
Context
GovInfoNow's records show CryoLife, Inc. has had five other recalls since May 14, 2018, including a Jan. 17, 2019 recall for mislabeled serial numbers on On-X Aortic Heart Valves. Other recent recalls of similar products include the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026), the Boston Scientific FARASTAR PFA Generator Recall (June 11, 2026), and the LeMait Artegraft Vascular Graft Recall (Feb. 10, 2026).
How to tell if you have this one
Check for model number SGPH00, serial number 10978889, or lot number 144125 on the product. The product was sold with an expiration date of 05/16/2022.
Brand
CryoLife
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labeling
Verify the model number, serial number, and lot number on the product to confirm if it is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide in the state of California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0121-2019 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0121-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.