BG3515-5 US 5mL BioGlue Surgical Adhesive — Class II medical device recall Z-1674-2014
Terminated recall by CryoLife, Inc., reported 2014-06-11, distributed nationwide. Serum albumin component monomer failed to meet internally established end of shelf-life specification.
| Recall number | Z-1674-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2014-04-25 |
| Classified | 2014-05-30 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-11-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,190 units |
Product
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).
Reason for recall
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1674-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.