FDA Device recall Z-0356-2024
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of stryker Sage PrimaFit External Urine Management System for the Female Anatomy by Sage Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0356-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-23 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sage Products |
| Distribution | n/a |
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
Identifiers
| code_info | GTIN 00618029600417, Lot Codes: 93667, 93614, 93613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0356-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.