Yoni.Fit Bladder Support PT-A-0015Recalls & reported problems

Watkins-Conti Products, Inc. · Yoni.Fit Bladder Support Kit Four: Includes Sizes 1, 2, and 3, Storage Container, Cleaning Brush, and Instructions for Use · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850019563269), received between May 18, 2026 and May 18, 2026 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Kidney Infection1
Urinary Tract Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
AFTER FLYING ON FRIDAY, (B)(6), THE PATIENT STATED THAT SHE EXPERIENCED FLU-LIKE SYMPTOMS. PATIENT STATED SHE REMOVED THE DEVICE AND DID NOT REINSERT. THE PATIENT REPORTED EXPERIENCING LOW-GRADE FEVER AND VOMITING AND ON MONDAY ON (B)(6), THE PATIENT REPORTED THAT SHE SAW HER PRIMARY CARE PHYSICIAN. PATIENT REPORTS THE PHYSICIAN DIAGNOSED HER WITH UTI AND KIDNEY INFECTION. PATIENT REPORTED SHE WAS TREATED WITH ANTIBIOTICS.
Patient problems: Kidney Infection; Urinary Tract Infection
MAUDE report 25209394 ↗

Device details

UDI-DI	`00850019563269`
Brand	Yoni.Fit Bladder Support
Model	PT-A-0015
Catalog no.	Yoni Fit Kit Four
Company	Watkins-Conti Products, Inc.
Product code	HHW · Pessary, Vaginal
Class	Class 2
FDA submission	K232525
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 7, 2026

Device type (GMDN): Urinary-incontinence vaginal insert, single-use

A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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