BioGlue Surgical Adhesive — Class II medical device recall Z-2623-2017
Terminated recall by CryoLife, Inc., reported 2017-07-05. The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
| Recall number | Z-2623-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2017-05-19 |
| Classified | 2017-06-23 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2019-02-08 |
| Countries outside the US | JP |
| Quantity | 705 single |
| Reason classes | labeling |
| Lot numbers | 17MJX002 |
| Model numbers | BG3510-5-J |
Product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Reason for recall
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
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-2623-2017. 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.