The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0381-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Swab System

Sage Products Inc. is recalling Toothette Oral Care Suction Swab Systems 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 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly when involving cross-contamination with non-pharmaceutical products which poses a significant risk of harm.

Plain-English summary

Sage Products Inc. is recalling 5,303 cases of the Toothette Oral Care Suction Swab System with Perox-A-Mint Solution. The product includes suction swabs, suction toothbrushes, applicator swabs, and mouth moisturizer. 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. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 52573, 52926, 53596, and others with expiration dates ranging from October 2017 to December 2018.

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

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, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
5,303

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: 6552
  • Lots: 52573
  • 52926
  • 53596
  • EXP 10/03/2017
  • 53610
  • 54288
  • EXP 12/19/2017
  • 54723
  • EXP 02/27/2018
  • 55878
  • 55890
  • 56617
  • 56637
  • EXP 04/24/2018
  • 56644
  • 56647
  • 56652
  • 57299
  • 57317

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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