Ferndale Laboratories recalled 24,589 vials of Mastisol Liquid Adhesive due to a defect. The butyrate tube may crack during use, making the product unusable. The recall affects products distributed in the U.S. and the U.K., announced on November 25, 2025.
Butyrate tube cracks during actuation, rendering product unusable.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ferndale Laboratories, Inc. or your healthcare provider for instructions. Notification method: Letter
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Mastisol Liquid Adhesive is sold in 2/3 mL vials, with 48 vials per carton. The model number is 0523-48. The affected lot code is Lot 24161B, with an expiration date of October 31, 2029.
The butyrate tube may crack during actuation. This defect can cause the product to become unusable, posing a risk to patients and healthcare providers.
No specific incidents or injuries have been reported at this time. The high hazard level indicates potential risks during use.
Stop using the product immediately. Follow the recall instructions provided by the manufacturer and contact Ferndale Laboratories or your healthcare provider for further instructions.
For more information, visit the FDA recall page or contact Ferndale Laboratories, Inc. directly at their customer service.
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