The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0392-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross-Contamination

Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a theoretical risk of cross-contamination without reporting specific illnesses or injuries, aligning with the criteria for a Moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 672 cases of Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. The product contains one suction toothbrush with sodium bicarbonate, 0.25 fl oz/7ml of antiseptic oral rinse, 0.07 oz/2g of mouth moisturizer, and one applicator swab. The affected lots are 57938 (EXP 09/19/2017), 59802 (EXP 01/08/2018), and 61329 (EXP 03/05/2018), identified by Product Code 6673.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment use creates a risk of cross-contamination with other products.

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 or a refund.

The recalled product

Product
Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
672

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 (7)

  • Product Code: 6673
  • Lots: 57938
  • EXP 09/19/2017
  • 59802
  • EXP 01/08/2018
  • 61329
  • 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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