CryoLife, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0384-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BioGlue Surgical Adhesive, Model BG3510-5-G

Product Classification:

Class II

Date Initiated: October 7, 2021

Date Posted: December 22, 2021

Recall Number: Z-0384-2022

Event ID: 88929

Reason for Recall:

Product is not approved for use in the EU and should not have been distributed in the EU.

Status: Terminated

Product Quantity: 156 5-pack box units

Code Information:

Model BG3510-5-G, Lot BG000255

Distribution Pattern:

Distribution in the European Union only (Germany/Switzerland)

Voluntary or Mandated:

Voluntary: Firm initiated