The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0378-2018·Announced 2018-02-21

Sage Products Recalls Oral Cleaning Systems Due to Cross-Contamination

Sage Products Inc. is recalling 852 cases of Oral Cleaning and Suctioning System q2 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 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or significant injury risks, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

Sage Products Inc. is voluntarily recalling 852 cases of the Oral Cleaning and Suctioning System q2. The product includes covered Yankauers, suction toothbrushes, suction oral swabs, and oropharyngeal suction catheters. The recall is due to cross-contamination, 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 6502 and UPC 6 18029 80060 2. Specific lots include 57627 (EXP 08/14/2017), 58677 (EXP 10/02/2017), 60110 (EXP 01/02/2018), and 61463 (EXP 03/30/2018). The products were 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 affected products and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care / Medical Supplies
Hazard
Affected units
852

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 (9)

  • Product Code: 6502
  • Lots: 57627
  • EXP 08/14/2017
  • 58677
  • EXP 10/02/2017
  • 60110
  • EXP 01/02/2018
  • 61463
  • EXP 03/30/2018.

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 →

Related recalls

Same manufacturer · Sage Products Inc

See all →

Same hazard · cross contamination

See all →

Similar recalls