CLASS II Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report

Q.Care Oral Cleansing & Suctioning System Suction recalled

Sage Products is recalling Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 6922-B; Lots: 53070, EXP 08/31/2017; 54452, EXP 10/31/2017; 56283, EXP 12/31/2017; 57710, EXP 02/28/2018; 58350, EXP 04/30/2018; 59528, 59539 EXP 07/31/2018; 60468, EXP 08/31/2018.

Quantity recalled480 Cases

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0403-2018
FDA event ID: 77992
Recalling firm: Sage Products, Cary, IL
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2017
FDA classified: 9 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Sunscreen & Personal Care

Timeline

22 Aug 2017	Recall initiated by company
9 Feb 2018	Classified by FDA	+171 days
21 Feb 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922-B UPC 6 18029 83032 6

Where it was distributed

Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Which lots are affected?

Product Code: 6922-B; Lots: 53070, EXP 08/31/2017; 54452, EXP 10/31/2017; 56283, EXP 12/31/2017; 57710, EXP 02/28/2018; 58350, EXP 04/30/2018; 59528, 59539 EXP 07/31/2018; 60468, EXP 08/31/2018.

Where was it sold?

Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

63 other products · FDA event 77992

This product is part of a recall event; the main page for the event is Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled.

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q Care RX Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Suction Toothbrush with Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Short-Term Oral Swab System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrushes recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q Care Continue Care for the non-ventilated patient recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Oral Cleansing & Suctioning System q2 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q Care Oral Cleansing & Suctioning System compatible recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care, Oral Cleansing & Suctioning System q4 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q Care Continue Care for the non-ventilated patient recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Oral Cleaning and Suctioning System q2 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.CareOral Cleansing & Suctioning System q2 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Perox-A- Mint solution recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Q Care & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Nose to Toes Skin Antisepsis, Oral Cleansing recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Independent Care System Corinz, Contains recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	QCare Rx Oral Cleansing and Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Swab System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System Suction recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Single Use System recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System Suction recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Single Use System With Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q Care RX Petite Oral Cleansing & Suctioning System recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Petite Size Oral Cleansing & Suctioning System recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Perox-A-Mint Solution recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Single Use System recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrush recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Oral Cleansing & Suctioning System q4 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	QCare Oral Cleansing and Suctioning System with Corinz recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Short Term Oral Swab System with Perox-A-Mint Solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Short Term Oral Care System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Swab System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System q8 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.CARE Oral Cleansing & Suctioning System q4 recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q Care RX Petite Oral Cleansing & Suctioning System recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Short Term Oral Swab System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Antiseptic Oral Rinse Sage Products recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System Suction recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Swabs recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q Care, Oral Cleansing & Suctioning System Corinz recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Daily Oral Cleansing Kit Petite Size recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Short Term Oral Swab System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	QCare RX Q2 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Skin antisepsis and oral cleansing recalled by Sage Products	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q CARE q4 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q.Care Petite Size Oral Cleansing & Suctioning System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Swab System With Antiseptic recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Short Term Oral Swab System recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q.Care Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q CARE q4 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Swabs with Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled	Sage Products	Other	Nationwide
21 Feb 2018	CLASS II	Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide
21 Feb 2018	CLASS II	Q CARE q4 Oral Cleaning & Suctioning System Contains recalled	Sage Products	Packaging Defects	Nationwide

More recalls from Sage Products

All 72

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate	Sage Products	Other	Nationwide
29 Nov 2023Device	CLASS II	stryker Sage PrimaFit External Urine Management System recalled	Sage Products	Labeling Errors	IL
14 Aug 2019Device	CLASS II	Toothete Oral Care Sodium Bicarbonate Mouthpaste recalled	Sage Products	Other	Nationwide
21 Feb 2018Drug	CLASS II	Q CARE q4 Oral Cleaning & Suctioning System Contains recalled	Sage Products	Packaging Defects	Nationwide
21 Feb 2018Drug	CLASS II	Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products	Sage Products	Packaging Defects	Nationwide