BioGlue Surgical Adhesive recalled for unauthorized distribution in European Union
CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as FDA Class II with no reported illnesses, injuries, or documented safety incidents. The recall addresses unauthorized distribution in an unapproved market region, which is a regulatory compliance issue rather than a known product safety defect.
Plain-English summary
BioGlue Surgical Adhesive, Model BG3510-5-G, manufactured by CryoLife, Inc., was recalled due to unauthorized distribution in the European Union. The product is not approved for use in the EU and should not have been distributed in that region.
The recall affects 156 units of the 5-pack box format with Lot BG000255 that were distributed in Germany and Switzerland. Healthcare facilities and patients in these regions who have this product in use should consult with their healthcare provider regarding any questions or concerns.
The recalled product
- Product
- BioGlue Surgical Adhesive, Model BG3510-5-G
- Manufacturer
- CryoLife, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model BG3510-5-G
- Lot BG000255
Distribution
Distribution scope not specified by the agency.
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