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Recall Observatory FDA recall evidence

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

Z-1005-2026

November 25, 2025

Class II

Product summary

Firm
Ferndale Laboratories, Inc.
Event
Event 98035
Status
Ongoing
Classification
Class II
Quantity
24589
Official record key
device-enforcement:Z-1005-2026

Official wording

Reason: Butyrate tube cracks during actuation, rendering product unusable.

Code information: Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488

Distribution pattern: Worldwide distribution - US Nationwide and the country of UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Butyrate tube cracks during actuation, rendering product unusable.