Revive Reusable Bladder Support — Class II medical device recall Z-1952-2019
Terminated recall by Rinovum Women's Health, reported 2019-07-17, distributed nationwide. The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" aft
| Recall number | Z-1952-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rinovum Women's Health, Monroeville, PA, United States |
| Recall initiated | 2019-05-02 |
| Classified | 2019-07-09 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2019-11-12 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | 75770223 |
| Model numbers | 0025 |
Product
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.
Reason for recall
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
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-1952-2019. 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.