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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Mastisol Liquid Adhesive Recalled for Cracking Vials

Agency Publication Date: December 31, 2025
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Summary

Ferndale Laboratories, Inc. is recalling 24,589 units of Mastisol Liquid Adhesive because the internal tube (butyrate tube) may crack when the vial is activated. This defect makes the adhesive unusable and prevents it from being applied correctly. The recall affects the 2/3 mL vials sold in cartons of 48 under catalog number 0523-48.

Risk

When the tube cracks during use, the liquid adhesive cannot be dispensed, which may lead to medical dressings or devices failing to stay securely attached to a patient's skin.

What You Should Do

  1. This recall affects Mastisol Liquid Adhesive sold in cartons of 48 vials (2/3 mL each) with catalog number 0523-48.
  2. Check the packaging for lot number 24161B and an expiration date of 10-31-2029.
  3. Stop using the recalled product immediately.
  4. Contact Ferndale Laboratories, Inc. or your distributor to arrange for a return, replacement, or correction of the affected vials.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Mastisol Liquid Adhesive (2/3 mL vial, 48 vials per carton)
Model / REF:
0523-48
UPC Codes:
3040960523488
Lot Numbers:
24161B (Exp 10-31-2029)
UDI:
00304960523488
GTIN:
3040960523488

Butyrate tube cracks during actuation, rendering product unusable.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98035
Status: Active
Manufacturer: Ferndale Laboratories, Inc.
Sold By: medical distributors
Manufactured In: United States
Units Affected: 24589
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.