The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0380-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Swab System

Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System because oral care solutions 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 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 describes a theoretical risk of cross-contamination without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is voluntarily recalling the Toothette Oral Care Suction Swab System with Perox-A-Mint Solution. The product includes suction swabs, applicator swabs, and mouth moisturizer. The recall involves 11,194 cases of the product.

The recall is being conducted because oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, creating a risk of cross-contamination. The affected lots have expiration dates ranging from August 2017 to May 2019.

The product was distributed nationwide in the United States 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 the manufacturer for a refund or replacement.

The recalled product

Product
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
11,194

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: 6550
  • Lots: 51590
  • EXP 08/15/2017
  • 52134
  • EXP 09/19/2017
  • 52179
  • EXP 09/26/2017
  • 52589
  • EXP 10/24/2017
  • 52966
  • EXP 11/07/2017
  • 53692
  • EXP 01/03/2018
  • 53883
  • EXP 01/16/2018
  • 54371
  • 54422
  • EXP 02/20/2018
  • 54622
  • 54677

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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