PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported March 4, 2015

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.

The toothbrush head can potentially disengage from the handle.

Recall #
Z-1213-2015
Affected scope
35,214
Initiated
February 3, 2015
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Norwex Usa Inc recalled Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy Th… - a moderate-severity action.

Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy Th… was recalled by Norwex Usa Inc in March 4, 2015. Reason: The toothbrush head can potentially disengage from the handle.. Check the official notice for the remedy. Verify recall #Z-1213-2015 with the FDA Devices before acting.

The recall

Norwex Usa Inc issued this moderate-severity FDA Devices recall-The toothbrush head can potentially disengage from the handle..

Moderate
severity level
35K units
affected scope
Class II
classification
March 4, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1213-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1213-2015) was formally reported on March 4, 2015, with the manufacturer initiating the action on February 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Norwex Usa Inc is listed as the recalling firm, operating out of Addison, TX. Federal records list the affected scope as 35,214.

The documented reason for this recall is: The toothbrush head can potentially disengage from the handle. Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,861 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,787
Severity1902064468High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1213-2015
Date reported March 4, 2015
Date initiated February 3, 2015
Recalling firm Norwex Usa Inc
Firm location Addison, TX
Affected scope 35,214
Distribution Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

35,214 units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1213-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Norwex Usa Inc. Units affected: 35,214.
Why was this product recalled?
The toothbrush head can potentially disengage from the handle.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 4, 2015. Severity: Moderate. Recall number: Z-1213-2015.
Where was the recalled product distributed?
Distribution: Nationwide Distribution.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… → · All Medical Devices recalls

This recall: FDA Devices, reported March 4, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026