BioGlue Surgical Adhesive (CryoLife) – Unauthorized EU Distribution (2021)
Product distributed incorrectly may require administrative correction.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioGlue Surgical Adhesive, Model BG3510-5-G
Brand
CryoLife, Inc.
Lot Codes / Batch Numbers
Model BG3510-5-G, Lot BG000255
Products Sold
Model BG3510-5-G, Lot BG000255
CryoLife, Inc. is recalling BioGlue Surgical Adhesive, Model BG3510-5-G due to Product is not approved for use in the EU and should not have been distributed in the EU.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is not approved for use in the EU and should not have been distributed in the EU.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026