Class II — Sage Products Inc
| Recalling firm | SAGE PRODUCTS LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| Product | stryker Sage PrimaFit External Urine Management System for the Female Anatomy |
| Quantity | 174,960 devices |
| Distribution | US and Canada |
| Initiated | 2023-10-23 |
| Classified | 2023-11-20 |
| Recall number | Z-0356-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sage Products Inc (Z-0356-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93229/
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