BioGlue Surgical Adhesive — Class II medical device recall Z-0384-2022
Terminated recall by CryoLife, Inc., reported 2021-12-22. Product is not approved for use in the EU and should not have been distributed in the EU.
| Recall number | Z-0384-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2021-10-07 |
| Classified | 2021-12-15 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2023-10-23 |
| Countries outside the US | CH, DE |
| Reason classes | unapproved product |
| Lot numbers | BG000255 |
| Model numbers | BG3510-5-G |
Product
BioGlue Surgical Adhesive, Model BG3510-5-G
Reason for recall
Product is not approved for use in the EU and should not have been distributed in the EU.
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-0384-2022. 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.