Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sage Products with 70 drug recalls, 31 510(k) clearances, 2 device recalls and 1 drug application. The most recent is a drug recall dated Aug 18, 2026: 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 18, 2026 | 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53Class II · Cross Contamination with Other Products | Drug recalls |
| Oct 23, 2023 | stryker Sage PrimaFit External Urine Management System for the Female AnatomyClass II · A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is | Device recalls |
| Dec 5, 2018 | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care conveClass II · A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouth | Device recalls |
| Apr 30, 1998 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK972705 · FMI | 510(k) clearances |
| Feb 24, 1998 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK980490 · MMK | 510(k) clearances |
| Oct 29, 1997 | 2 GALLON ALTERNATE CARE SHARPS CONTAINERK973911 · FMI | 510(k) clearances |
| Aug 29, 1997 | SHARPS SHUTTLEK972279 · FMI | 510(k) clearances |
| Aug 25, 1997 | NITRILE GLOVESK970135 · LZC | 510(k) clearances |
| Jul 25, 1997 | POCKET COUNT OR SAFETCOUNTK972302 · LWH | 510(k) clearances |
| Mar 3, 1997 | PROCEDURE SPECIFIC KITSK964168 · FXX | 510(k) clearances |
| Nov 8, 1996 | STP SYSTEM PVA WITH ZINCK963986 · LIO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
