The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0368-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Suction Swab System

Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System 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 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 adverse health consequences from contamination, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is recalling 640 cases of the Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. The affected product includes 2 suction swabs with sodium bicarbonate, 0.25 fl oz/7ml of antiseptic oral rinse, and 0.7 oz/2g of mouth moisturizer. The recall involves specific lots: 58483 (EXP 10/09/2017), 59783 (EXP 01/08/2018), and 61117 (EXP 03/05/2018).

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, leading to cross-contamination. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected units were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
640

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 (7)

  • Product Code: 6115
  • Lots: 58483
  • EXP 10/09/2017
  • 59783
  • EXP 01/08/2018
  • 61117
  • EXP 03/05/2018.

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