Toothete Oral Care Sodium Bicarbonate Mouthpaste — Class II medical device recall Z-2139-2019
Terminated recall by Sage Products Inc, reported 2019-08-14, distributed nationwide. A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbo
| Recall number | Z-2139-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products Inc, Cary, IL, United States |
| Recall initiated | 2018-12-05 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-06-15 |
| Distributed | Nationwide (US) |
| Lot numbers | 67924 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2139-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.