FDA recall Z-1005-2026

Ferndale Laboratories, Inc. · Class II · device

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

Reason for recall

Butyrate tube cracks during actuation, rendering product unusable.

Distribution

Worldwide distribution - US Nationwide and the country of UK.

Key facts

Status
Ongoing
Initiation date
2025-11-25
Report date
2026-01-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ferndale, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1005-2026