Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Li
FDA device recall Z-1005-2026 · posted 2025-12-31 · Open, Classified
Recall details
- Recalling firm
- Ferndale Laboratories, Inc.
- Reason for recall
- Butyrate tube cracks during actuation, rendering product unusable.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KGX
- Quantity affected
- 24589
- Distribution
- Worldwide distribution - US Nationwide and the country of UK.
- Date initiated
- 2025-11-25
- Date posted
- 2025-12-31
- Location
- Ferndale, MI
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