Recall Ledger

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog... recall (Ferndale Laboratories, Inc.)

Medical deviceClass IIOngoing

Summary: Ferndale Laboratories, Inc. is recalling 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.

What is being recalled

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

Why

Butyrate tube cracks during actuation, rendering product unusable.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the country of UK.

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1005-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedNovember 25, 2025
ReportedJanuary 7, 2026
CompanyFerndale Laboratories, Inc.
Company locationFerndale, MI, United States
Initiated byVoluntary: Firm initiated
Quantity24589

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