The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0370-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Toothbrushes

Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 887 cases of Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer. The product contains two suction toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml of antiseptic oral rinse, and 0.07 oz/2g of mouth moisturizer. The affected product code is 6173, with lots 57899, 58919, 60058, and 61135.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, resulting in cross-contamination. The FDA has classified this recall as Class II.

The affected units were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers should stop using the product and contact Sage Products Inc. for further instructions.

The recalled product

Product
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
887

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Product Code: 6173
  • Lots: 57899
  • EXP 09/19/2017
  • 58919
  • EXP 11/15/2017
  • 60058
  • EXP 01/08/2018
  • 61135
  • EXP 03/05/2018.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 64 recalled by Sage Products Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 64 products in this recall →

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