The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0382-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Toothbrushes

Sage Products is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution due to potential cross-contamination with non-pharmaceutical products.

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 corresponds to a moderate severity level involving a reasonable probability of temporary or medically reversible adverse health consequences, without reported serious injuries or deaths.

Plain-English summary

Sage Products, Inc. is recalling 6,472 cases of Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. The product contains two suction toothbrushes with sodium bicarbonate and 0.25 fl oz/7ml of Perox-A-Mint solution. The recall is due to cross-contamination with other products, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected product was distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. The recall includes specific lots with expiration dates ranging from August 15, 2017, to May 14, 2019.

Consumers should stop using the affected product and contact Sage Products, Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
6,472

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 (20)

  • Product Code: 6570
  • Lots: 51571
  • EXP 08/15/2017
  • 52105
  • EXP 09/19/2017
  • 53077
  • EXP 11/14/2017
  • 54259
  • EXP 02/06/2018
  • 55243
  • 04/10/2018
  • 56167
  • EXP 06/12/2018
  • 56874
  • EXP 07/31/2018
  • 57748
  • EXP 09/18/2018
  • 59258
  • EXP 11/20/2018
  • 60144

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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