---
title: "stryker Sage PrimaFit External Urine Management System for the Female Anatomy — FDA record Z-0356-2024 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0356-2024-stryker-sage-primafit-external-urine-management-system-for-the-female-anatomy/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# stryker Sage PrimaFit External Urine Management System for the Female Anatomy — FDA record Z-0356-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Sage Products Inc
- **Quantity**: 174,960 devices
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0356-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0356-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GTIN 00618029600417, Lot Codes: 93667, 93614, 93613 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US and Canada

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 29, 2023
- **Recall initiation date**: Oct 23, 2023
- **Center classification date**: Nov 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0356-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Sage Products Inc records](https://isitonrecall.com/brand/sage-products-inc/)