Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.