The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0351-2018·Announced 2018-02-21

Sage QCare Oral Cleansing System Recalled for Cross-Contamination Risk

Sage Products Inc. is recalling QCare Oral Cleansing and Suctioning Systems with Corinz 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 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 FDA classified this as a Class II recall, and the source text describes a theoretical cross-contamination risk without reporting specific illnesses or injuries, aligning with the rubric for moderate severity.

Plain-English summary

Sage Products Inc. is voluntarily recalling 1,680 kits of the QCare Oral Cleansing and Suctioning System with Corinz. The product includes suction toothbrushes and oral swabs with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. 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 is identified by Product Code 6464 and specific lot numbers with expiration dates ranging from August 2017 to October 2018. The recall covers distribution in the United States, Puerto Rico, Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand.

Consumers should stop using the product and contact Sage Products Inc. for instructions on return or disposal. 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
QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
1,680

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 (13)

  • Product Code: 6464
  • Lots: 55175 EXP 8/28/2017
  • 57086
  • 58011
  • EXP 11/13/2017
  • 58604
  • EXP 4/3/2018
  • 60373
  • EXP 8/2/2018
  • 60590
  • EXP 9/4/2018
  • 61540
  • EXP 10/16/2018.

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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