The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0383-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution because they were manufactured on equipment shared 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a severity score of 4 (Severe) per the rubric, as it involves a risk of temporary or medically reversible health problems.

Plain-English summary

Sage Products Inc. is voluntarily recalling 8,466 cases of Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. The product contains one suction toothbrush 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 products were 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 lot numbers with expiration dates ranging from November 2017 to May 2019. Consumers should check their products for the listed lot numbers and stop using them if they match.

The FDA has classified this recall as Class II, which means the product may cause temporary or medically reversible health problems. Consumers with questions about the recall should contact Sage Products Inc. for further instructions.

The recalled product

Product
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
8,466

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: 6571
  • Lots: 52384
  • EXP 10/03/2018
  • 53134
  • EXP 11/28/2017
  • 53387
  • EXP 12/05/2017
  • 54215
  • EXP 02/06/2018
  • 54967
  • EXP 03/28/2018
  • 55997
  • EXP 05/30/2018
  • 56180
  • EXP 06/12/2018
  • 56854
  • EXP 07/31/2018
  • 57334
  • EXP 08/21/2018
  • 58305

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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