---
title: "BioGlue Surgical Adhesive, Model BG3510-5-G — FDA record Z-0384-2022 | Is It on Recall"
description: "Product is not approved for use in the EU and should not have been distributed in the EU."
url: https://isitonrecall.com/recall/fda-device-z-0384-2022-bioglue-surgical-adhesive-model-bg3510-5-g/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# BioGlue Surgical Adhesive, Model BG3510-5-G — FDA record Z-0384-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 7, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: BioGlue Surgical Adhesive, Model BG3510-5-G
- **Reason**: Product is not approved for use in the EU and should not have been distributed in the EU.
- **Classification**: Class II
- **Recalling firm**: CryoLife, Inc.
- **Quantity**: 156 5-pack box units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0384-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0384-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model BG3510-5-G, Lot BG000255 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution in the European Union only (Germany/Switzerland)

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 22, 2021
- **Recall initiation date**: Oct 7, 2021
- **Center classification date**: Dec 15, 2021
- **Termination date**: Oct 23, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0384-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [CryoLife, Inc. records](https://isitonrecall.com/brand/cryolife-inc/)