FDA Enforcement
Class II
Ongoing
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
Recall: Z-1005-2026
·
Reported January 7, 2026
Enforcement
- Recall Number
- Z-1005-2026
- Event ID
- 98035
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ferndale Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 7, 2026
- Initiation Date
- November 25, 2025
- Classification Date
- December 31, 2025
- Address
- 780 W 8 Mile Rd, N/A, Ferndale, MI, 48220-2422, United States
Description
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
Reason
Butyrate tube cracks during actuation, rendering product unusable.
Code Info
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Distribution
Worldwide distribution - US Nationwide and the country of UK.
Quantity
24589