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Open, Classified

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

FDA Recall Z-1005-2026 · Posted 2025-12-31

Recalling FirmFerndale Laboratories, Inc.
Recall StatusOpen, Classified
Product CodeKGX
Date Initiated2025-11-25
Product Quantity24589

Reason for Recall

Butyrate tube cracks during actuation, rendering product unusable.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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