Accueil/Tous les Rappels/FDA-Z-1005-2026
FDA DevicesClass II

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

Publié le: 7 janvier 2026ID du rappel: Z-1005-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

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

Recalling Firm: Ferndale Laboratories, Inc.

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Butyrate tube cracks during actuation, rendering product unusable.

Description du produit & Identification

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

Produits concernés

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

Additional Source Details

FieldValue
CityFerndale
StateMI
Event id98035
Address 1780 W 8 Mile Rd
Address 2N/A
Code infoLot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Postal code48220-2422
Report date20260107
Product typeDevices
Product quantity24589
Reason for recallButyrate tube cracks during actuation, rendering product unusable.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251125
Initial firm notificationLetter
Center classification date20251231

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Aperçu

  • Entreprise responsableFerndale Laboratories, Inc.
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionWorldwide distribution - US Nationwide and the country of UK.
Recall Hazard Severity
High Alert (Class I)
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🚨 SAFETY ALERT: Ferndale Laboratories, Inc. - 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

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