FDA Device recall Z-0384-2022
BioGlue Surgical Adhesive, Model BG3510-5-G
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of BioGlue Surgical Adhesive, Model BG3510-5-G by Cryolife, citing product is not approved for use in the EU and should not have been distributed in the EU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0384-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-07 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cryolife |
| Distribution | n/a |
Product
BioGlue Surgical Adhesive, Model BG3510-5-G
Reason
Product is not approved for use in the EU and should not have been distributed in the EU.
Identifiers
| code_info | Model BG3510-5-G, Lot BG000255 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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FDA Device · Class II · 2020-12-30 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Device · Class II · 2018-10-24 · Cryolife
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0384-2022%22
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