Class 2 Device Recall Mastisol Liquid Adhesive

• Date Initiated by Firm: November 25, 2025
• Date Posted: December 31, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1005-2026
• Recall Event ID: 98035
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: 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
• Code Information: Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
• FEI Number: 1811212
• Recalling Firm/ Manufacturer: Ferndale Laboratories, Inc.; 780 W 8 Mile Rd; Ferndale MI 48220-2422
• For Additional Information Contact: 248-548-0900
• Manufacturer Reason for Recall: Butyrate tube cracks during actuation, rendering product unusable.
• FDA Determined 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 in Commerce: 24589
• Distribution: Worldwide distribution - US Nationwide and the country of UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.