FDA Medical devices recall ·
Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model recall
- Recall number
- Z-1005-2026
- Date
- (initiated November 25, 2025)
- Company / brand
- Ferndale Laboratories, Inc.
780 W 8 Mile Rd, Ferndale, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 24589
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Butyrate tube cracks during actuation, rendering product unusable.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Distribution
Worldwide distribution - US Nationwide and the country of UK.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1005-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.