Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

stryker Sage PrimaFit External Urine Management System for the Female Anatomy Recalled by Sage Products Inc Due to A small percentage of devices in three lots...

Date: October 23, 2023
Company: Sage Products Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sage Products Inc directly.

Affected Products

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Quantity: 174,960 devices

Why Was This Recalled?

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

Where Was This Sold?

US and Canada

About Sage Products Inc

Sage Products Inc has 68 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report