Ferndale Laboratories, Inc. recalls Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Numb…
Reason for recall
Butyrate tube cracks during actuation, rendering product unusable.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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: No5 affected lots24161B10-31-202900304960523488UPC/GTIN-123040960523488
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the country of UK.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1005-2026
- FDA device classification · KGXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5240The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Ferndale Laboratories, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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