Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:
Summary
The FDA issued a Class II for Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catal by Ferndale Laboratories, Inc.. Reason: Butyrate tube cracks during actuation, rendering product unusable..
Details
Source
Device Recall
External ID
Z-1005-2026
Action Date
2026-01-07
Status
Ongoing
Category
device
Product 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
Lot/Code Info: Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Quantity Affected: 24589
Reason for Recall
Butyrate tube cracks during actuation, rendering product unusable.
Distribution
Worldwide distribution - US Nationwide and the country of UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-25
Company
Ferndale, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ferndale Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ferndale Laboratories, Inc. have FDA actions?
This is the only FDA action we have on record for Ferndale Laboratories, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1005-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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