BioGlue Spreader Tip — Class II medical device recall Z-2556-2018
Terminated recall by CryoLife, Inc., reported 2018-08-01. The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied
| Recall number | Z-2556-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2018-06-04 |
| Classified | 2018-07-26 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-02-08 |
| Countries outside the US | JP |
| Quantity | 855 total |
| Reason classes | labeling |
| Lot numbers | 18MJX002 |
| Model numbers | BG3510-5-J |
Product
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
Reason for recall
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2556-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.