Z-1005-2026Class II

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product...

Name: Z-1005-2026 Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product...
Creator: Ferndale Laboratories, Inc.
Published: 2025-11-25
License: https://open.fda.gov/license/

Ferndale Laboratories, Inc. / initiated 2025-11-25 / Open, Classified / root cause: manufacturing process

FDA source

Ferndale Laboratories, Inc. began a recall of Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials... on 2025-11-25. FDA classified it as Class II and gives the reason as "Butyrate tube cracks during actuation, rendering product unusable". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1005-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-25
Posted: 2025-12-31
Recalling firm: Ferndale Laboratories, Inc.
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
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: Butyrate tube cracks during actuation, rendering product unusable.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 24589
Distribution: Worldwide distribution - US Nationwide and the country of UK.
Product codes and lots: Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1005-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-07	2025-12-31

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)