The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0395-2018·Announced 2018-02-21

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

Sage Products Inc. 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Sage Products Inc. is voluntarily recalling 2,970 cases of the Q.Care Oral Cleansing & Suctioning System q2. The product contains various oral care components, including suction handles, toothbrushes, and swabs with antiseptic or mouthwash solutions. The recall is due to a risk of cross-contamination, as the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products.

The affected product is identified by Product Code 6802 and UPC 6 18029 84120 9. Specific lots involved include 57509, 58122, 58203, 58978, 59724, 60556, and 61241, with expiration dates ranging from August 2017 to February 2018. The products were distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand.

Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,970

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 (15)

  • Product Code: 6802
  • Lots: 57509
  • EXP 08/14/2017
  • 58122
  • EXP 09/11/2017
  • 58203
  • EXP 10/02/2017
  • 58978
  • EXP 11/03/2018
  • 59724
  • EXP 11/27/2017
  • 60556
  • EXP 02/05/2018
  • 61241
  • EXP 02/23/2018

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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