Rinovum Women's Health: Medical Device Recall in 2019 - (Recall #: Z-1952-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 2, 2019

Date Posted: July 17, 2019

Recall Number: Z-1952-2019

Event ID: 83023

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).

Status: Terminated

Product Quantity: 1024 (180 distributed from distributor)

Code Information:

Lot 75770223

Distribution Pattern:

US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated