“CryoLife BioGlue Surgical Adhesive Model BG351: EU Distribution Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61712-cryolife-bioglue-surgical-adhesive-model-bg351-eu-distribution-issue. Based on FDA recall #Z-0384-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0384-2022%22&limit=1).
CryoLife, Inc. recalled BioGlue Surgical Adhesive Model BG3510-5-G because it was distributed in the European Union without approval there, according to the FDA on October 7, 2021.
How to tell if you have it
Brand: CryoLife
Product: BioGlue Surgical Adhesive
Model: BG3510-5-G
Lot: BG000255
Quantity: 156 units (5-pack boxes)
Distribution: European Union (Germany/Switzerland)
The hazard
The product is not approved for use in the EU and should not have been distributed there, according to the FDA.
Context
GovInfoNow's records show CryoLife, Inc. has 5 other recalls on record since May 14, 2018. Other recent recalls include the CryoLife SG Pulmonary Heart Valve Recall for microbial test failures (November 10, 2020) and the CryoLife On-X Aortic Heart Valve Mislabeled Serial Number Recall (January 17, 2019).
How to tell if you have this one
Check for the model number BG3510-5-G on the product packaging. The product was distributed in the EU with lot number BG000255.
Brand
CryoLife
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number BG3510-5-G and lot number BG000255 on the product packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2 years 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-0384-2022 (October 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0384-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.