FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: BioGlue Surgical Adhesive, Model BG3510-5-G
- Recall number
- Z-0384-2022
- Recalling firm
- CryoLife, Inc.
- Product
- BioGlue Surgical Adhesive, Model BG3510-5-G
- Status
- Terminated
- Initiated
- 2021-10-07
- Posted
- not on file
- Terminated
- 2023-10-23
- Reason
- Product is not approved for use in the EU and should not have been distributed in the EU.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- 156 5-pack box units
- Distribution
- Distribution in the European Union only (Germany/Switzerland)
- Lot, serial or model codes
- Model BG3510-5-G, Lot BG000255
- 510(k) numbers
- not on file
- PMA numbers
- ["P010003"]
- Product code
- MUQ
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28