Quick Facts at a Glance
- Recall Date
- November 25, 2025
- Hazard Level
- HIGH
- Brand
- Ferndale Laboratories
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ferndale Laboratories
- Product type
- Liquid Adhesive
- Model numbers
- 0523-48, Lot Code: Lot 24161B, Expiration Date 10-31-2029, DI Number 00304960523488, UPC/GTIN-12 3040960523488
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 25, 2025
Reported by FDA DEVICE
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Butyrate tube cracks during actuation, rendering product unusable.
What You Should Do
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
About This Product
Mastisol Liquid Adhesive is a medical adhesive used for securing dressings and other medical devices. It is typically used in healthcare settings to provide a strong bond to the skin.
Why This Is Dangerous
The butyrate tube can crack during use, which prevents the adhesive from functioning properly. This defect can lead to a failure in securing medical devices, potentially impacting patient care.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the product immediately, as it poses a risk of malfunction during critical medical applications.
Practical Guidance
How to identify if yours is affected
- Check the model number for 0523-48
- Verify the lot code as Lot 24161B
- Look for the expiration date of October 31, 2029
Where to find product info
The model number, lot code, and expiration date can be found on the product packaging or label.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer
- Follow up regularly via phone or email
- Consider filing a complaint with the CPSC if no response
How to prevent similar issues
- Look for products with strong safety certifications
- Check for any recalls before purchase
- Be cautious of products with known defects or poor reviews
Documentation advice
Keep a copy of your purchase receipt and any correspondence related to the recall.
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Product Details
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.
Key Facts
- Recall date: November 25, 2025
- Quantity recalled: 24,589 vials
- Distribution: U.S. and U.K.
- Hazard level: High
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Safety Guide
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