The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0402-2018·Announced 2018-02-21

Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination

Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical cross-contamination risk, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Sage Products Inc. is recalling 6,461 cases of the Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. The product includes covered Yankauer and Y-Connector, suction toothbrush packages, suction oral swab packages with Perox-A-Mint solution or Alcohol-Free Mouthwash, and oropharyngeal suction catheter packages.

The recall was initiated because oral care solutions within the system were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This cross-contamination risk affects the safety of the oral care components.

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. Consumers and healthcare facilities should stop using the recalled product and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard
Affected units
6,461

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: 6922
  • Lots: 51408
  • EXP 08/10/2017
  • 51701
  • EXP 08/22/2017
  • 52782
  • EXP 10/31/2018
  • 53083
  • EXP 11/14/2017
  • 53746
  • EXP 01/09/2018
  • 54210
  • EXP 02/06/2018
  • 54868
  • EXP 03/21/2018
  • 55294
  • XP 04/17/2018
  • 55930
  • EXP 05/30/2018
  • 56555

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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