Recall Register

Sage Products Inc: FDA recalls

FDA enforcement reports name Sage Products Inc as the recalling firm in 5 events. The events have 68 product records. The recalls started from 2014 to 2023.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Sage Products Inc
InitiatedProduct (first record)TypeClassRecordsStatus
23 Oct 2023stryker Sage PrimaFit External Urine Management System for the Female AnatomyDeviceClass II1Ongoing
5 Dec 2018Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral…DeviceClass II1Terminated
22 Aug 2017Q.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 7DrugClass II64Terminated
2 Feb 2017Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing…DrugClass III1Terminated
27 Aug 2014Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013DrugClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Sage Products Inc: events for each product type
TypeEvents
Drug3
Device2
Sage Products Inc: events in each class
ClassEvents
Class II4
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Sage Products Inc, by the year that the recall started. The largest year is 2017, with 2 events.

Official channels

Cite this page

Recall Register. Sage Products Inc: FDA recalls. https://recallregister.com/firm/sage-products-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Sage Products Inc have?
Class II: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Sage Products Inc have?
Drug: 3 events. Device: 2 events.
What is the newest FDA recall of Sage Products Inc?
FDA event 93229, which the firm started on 23 Oct 2023. The first product in the record is: stryker Sage PrimaFit External Urine Management System for the Female Anatomy
How many FDA recalls of Sage Products Inc have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.