Z-0384-2022Class II

BioGlue Surgical Adhesive, Model BG3510-5-G

Name: Z-0384-2022 BioGlue Surgical Adhesive, Model BG3510-5-G
Creator: CryoLife, Inc.
Published: 2021-10-07
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2021-10-07 / Terminated

FDA source

CryoLife, Inc. began a recall of BioGlue Surgical Adhesive, Model BG3510-5-G on 2021-10-07. FDA classified it as Class II and gives the reason as "Product is not approved for use in the EU and should not have been distributed in the EU". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0384-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-07
Posted: 2021-12-15
Terminated: 2023-10-23
Recalling firm: Artivion, Inc.
Product: BioGlue Surgical Adhesive, Model BG3510-5-G
Product code: MUQ Glue, Surgical, Arteries
Reason for recall: Product is not approved for use in the EU and should not have been distributed in the EU.
FDA root cause: No Marketing Application
Action: A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.
Quantity in commerce: 156 5-pack box units
Distribution: Distribution in the European Union only (Germany/Switzerland)
Product codes and lots: Model BG3510-5-G, Lot BG000255

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0384-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0384-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-15

Product code MUQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)