Product Wiki · Recalls · U.S. FDA — Device Enforcement

Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt — recall Z-2139-2019

U.S. FDA — Device Enforcement · United States · 2018-12-05 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2139-2019
Date of alert
2018-12-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sage Products Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US nationwide distribution in the states CO, CT, GA, IN, CA.
Reported risk: A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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