Z-1952-2019Class II

Revive Reusable Bladder Support, Model No. 0025 -

Name: Z-1952-2019 Revive Reusable Bladder Support, Model No. 0025 -
Creator: Rinovum Women's Health
Published: 2019-05-02
License: https://open.fda.gov/license/

Rinovum Subsidiary 2, LLC / initiated 2019-05-02 / Terminated

FDA source

Rinovum Women's Health began a recall of Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by... on 2019-05-02. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1952-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-07-09
Terminated: 2019-11-12
Recalling firm: Rinovum Subsidiary 2, LLC
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.
Product code: HHW Pessary, Vaginal
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).
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 1024 (180 distributed from distributor)
Distribution: US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.
Product codes and lots: Lot 75770223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1952-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-09

Product code HHW

K183468Class IIRevive Reusable Bladder SupportRinovum Subsidiary 2, LLC / cleared 2019-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)