RecallRadar

FDA Drug recall D-0356-2018

Oral Cleansing & Suctioning System q4

On 2018-02-21 the FDA classified a Class II recall of Oral Cleansing & Suctioning System q4 by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0356-2018
ClassificationClass II
Statusterminated
Initiated2017-08-22
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanySage Products
DistributionUS

Product

Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 6

Reason

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

Identifiers

upc618029830456
code_info
Product Code: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 6…Product Code: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 61002, EXP 02/23/2018; 61817, EXP 03/21/2018; 61825, EXP 04/27/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0356-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.