CLASS II ONGOING Device recall · Reported 7 Jan 2026 · FDA Enforcement Report
Mastisol Liquid Adhesive Liquid Adhesive recalled
Ferndale Laboratories is recalling Mastisol Liquid Adhesive Liquid Adhesive, distributed nationwide in the US. The recall was initiated on 25 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1005-2026
- FDA event ID
- 98035
- Recalling firm
- Ferndale Laboratories, Ferndale, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Nov 2025
- FDA classified
- 31 Dec 2025
- Reported
- 7 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Nov 2025 | Recall initiated by company | |
| 31 Dec 2025 | Classified by FDA | +36 days |
| 7 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Butyrate tube cracks during actuation, rendering product unusable.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the country of UK.
Questions about this recall
Why was it recalled?
Butyrate tube cracks during actuation, rendering product unusable.
Which lots are affected?
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Where was it sold?
Worldwide distribution - US Nationwide and the country of UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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