Revive Bladder Support (Rinovum) – Premature Wear Risk (2019)
Product may split or crack during repeated use, potentially affecting device performance.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Rinovum Women's Health
Lot Codes / Batch Numbers
Lot 75770223
Products Sold
Lot 75770223
Rinovum Women's Health is recalling Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is inten due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
The firm began notifying affected retailers of the recall starting May 9, 2019. Retailers were asked to do the following: - Immediately remove affected product -Complete the verification form -File a claim against supplier and return the merchandise to the manufacturer Store questions may be directed to the Compliance Hotline at 700-925-6278.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026