CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Toothete Oral Care Sodium Bicarbonate Mouthpaste recalled
Sage Products is recalling Toothete Oral Care Sodium Bicarbonate Mouthpaste, distributed nationwide in the US. The recall was initiated on 5 Dec 2018 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-2139-2019
- FDA event ID
- 81745
- Recalling firm
- Sage Products, Cary, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2018
- FDA classified
- 2 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Dec 2018 | Recall initiated by company | |
| 2 Aug 2019 | Classified by FDA | +240 days |
| 14 Aug 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Product as listed by the FDA
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
Where it was distributed
US nationwide distribution in the states CO, CT, GA, IN, CA.
Questions about this recall
Why was it recalled?
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Which lots are affected?
Product Code 6004; Lot Number 67924; Reorder Number 6080
Where was it sold?
US nationwide distribution in the states CO, CT, GA, IN, CA.
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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