Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16856 |
| Brand Name: | Cryolife Bioglue Surgical Adhesive |
| Model: | CRY-BG3515-5 |
| Affected: | Lot No: all lot numbers pre 14MGV024 |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Artivion Inc |
| Issue: | At the request of the FDA the manufacturer has changed the expiration dating for Bioglue Surgical Adhesive from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet internally established end of shelf-life specification. The specification limit was set based on manufacturing capability at the time the process was first established. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/6/2014 |
