Brand Name: Mastisol Liquid Adhesive recallZ-1005-2026 · Ferndale Laboratories, Inc. · initiated Nov 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ferndale Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Butyrate tube cracks during actuation, rendering product unusable.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1005-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 25, 2025
- Posted by the FDA
- Dec 31, 2025
- Recalling firm
- Ferndale Laboratories, Inc.
- Quantity
- 24589
- Product code
- KGX
- Distribution
- Worldwide distribution - US Nationwide and the country of UK.
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
Code information (models, lots, serial numbers)
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MASTISOL 1Ferndale Laboratories, Inc. · Tape And Bandage, Adhesive1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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