The Recall Desk
ModerateFDA (Devices)·Z-0384-2022·Announced 2021-12-22

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.

What this means for you

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.
Category
Medical Device — Surgical Adhesive
Hazard
  • regulatory-non-compliance

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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