Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The produc...

FDA Device Recall #Z-1213-2015 — Class II — February 3, 2015

Recall Summary

Recall Number Z-1213-2015
Classification Class II — Moderate risk
Date Initiated February 3, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Norwex Usa Inc
Location Addison, TX
Product Type Devices
Quantity 35,214

Product Description

Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.

Reason for Recall

The toothbrush head can potentially disengage from the handle.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Model Number 354075, Light Blue; Model Number 354076, Green; Model Number 354077, Pink; Model Number 354078, Dark Blue

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.