Recall Z-1005-2026 ยท KGX Tape And Bandage, Adhesive
Ferndale Laboratories, Inc.
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
| Date | Dec 31, 2025 (initiated Nov 25, 2025) |
| Status | Open, Classified |
| Reason | Butyrate tube cracks during actuation, rendering product unusable. |
| Root cause | Process control |
| Action | On November 25, 2025, the firm issued Urgent Medical Device Recall letters to affected consignees. Consignees were instructed to quarantine Lot 24161B and return all units to Ferndale Laboratories. |
| Quantity | 24589 |
| Distribution | Worldwide distribution - US Nationwide and the country of UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.