Sage Products Inc: 66 FDA recall reports
Every drug recall the FDA has published for Sage Products Inc. The fault, and how the agency graded it.
66Reports
0Class I
0Ongoing
2018-02-21Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodi
D-0382-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 6472 Cases
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 C
D-0409-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002 UPC 6 18029 83025 8
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 4298 Cases
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox
D-0353-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 38,792 cases
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Sw
D-0360-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 25,409 cases
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction
D-0370-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6173
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 887 cases
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packag
D-0372-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 2,938 cases
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Y
D-0385-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 2424 Cases
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Cont
D-0408-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6994 UPC 6 18029 83094 4
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 1273 Cases
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbr
D-0348-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 1182 kits
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 C
D-0399-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 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 6912-S UPC 6 18029 83016 6
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 60 Cases
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packag
D-0371-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6306 UPC 6 18029 83041 8
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 5,217 cases
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages w
D-0378-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 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 Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 852 cases
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suc
D-0395-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 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 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6802 UPC 6 18029 84120 9
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 2970 Cases
Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Thr
D-0366-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 945 cases
Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector,
D-0389-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 2
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 2408 Cases
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorh
D-0411-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturi
D-0362-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 82148 5
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 94 cases
QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains
D-0352-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 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 6912 UPC 6 18029 83016 6
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 48,003 cases
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 C
D-0401-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 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 6914-S UPC 6 18029 83017 3
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 60 Cases
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs wit
D-0381-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6552 UPC 6 18029 82115 7
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 5303 Cases
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrus
D-0376-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 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, 4 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6422 UPC 6 18029 83031 9
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 5,579 cases
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Ora
D-0405-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 3928 Cases
Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette P
D-0369-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 879 cases
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Ora
D-0402-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 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 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 UPC 6 18029 83032 6
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 6461 Cases
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered
D-0387-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594 UPC 6 18029 82134 1
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 5138 Cases
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium
D-0364-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 14,753 cases
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 C
D-0400-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 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 6914 UPC 6 18029 83017 3
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 82072 Cases
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Conta
D-0406-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 633 Cases
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Conne
D-0393-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 6726 Cases
Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc
D-0350-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Product
- Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
- Where it went
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- How much
- 7490 PACKETS
Showing the 30 most recent of 66. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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