Sage Products Inc: Medical Device Recall in 2023 - (Recall #: Z-0356-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Product Classification:

Class II

Date Initiated: October 23, 2023

Date Posted: November 29, 2023

Recall Number: Z-0356-2024

Event ID: 93229

Reason for Recall:

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

Status: Ongoing

Product Quantity: 174,960 devices

Code Information:

GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated