Z-2623-2017Class II

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

Name: Z-2623-2017 BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Creator: CryoLife, Inc.
Published: 2017-05-19
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2017-05-19 / Terminated / root cause: labeling and UDI

FDA source

CryoLife, Inc. began a recall of BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J on 2017-05-19. FDA classified it as Class II and gives the reason as "The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2623-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Posted: 2017-06-23
Terminated: 2019-02-08
Recalling firm: Artivion, Inc.
Product: BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Product code: MUQ Glue, Surgical, Arteries
Reason for recall: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.
Quantity in commerce: 705 single pack boxes
Distribution: Product distributed in Japan.
Product codes and lots: Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2623-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

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)