stryker Sage PrimaFit External Urine Management System for the Female… — Class II medical device recall Z-0356-2024
Ongoing recall by Sage Products Inc, reported 2023-11-29. A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive
| Recall number | Z-0356-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products Inc, Cary, IL, United States |
| Recall initiated | 2023-10-23 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Countries outside the US | CA |
| Quantity | 174,960 devices |
| Reason classes | undeclared allergen, labeling |
| UPC / GTIN / UDI-DI | 00618029600417 |
| Lot numbers | 93613, 93614, 93667 |
Product
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0356-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.