Replens™ Long-Lasting Vaginal Moisturizer 00022600001041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00022600001041), received between Jan 13, 2025 and Jan 13, 2025 — 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.

Most reported problems

Recent adverse event reports

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

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT ((B)(4)) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A 64-YEAR-OLD FEMALE CONSUMER VIA THE HEALTH AUTHORITY (FDA MEDWATCH PROGRAM) AND FOLLOWED UP BY A SURVEY, WHO REPORTED SEVERE URINARY TRACT INFECTION, CHEST CONGESTION, AND COUGH AFTER USING THE REPLENS VAGINAL MOISTURIZER REUSABLE APPLICATOR. ON AN UNSPECIFIED DATE (PRIOR TO THE SYMPTOMS STARTING), THE CONSUMER INITIATED REPLENS VAGINAL MOISTURIZER REUSABLE APPLICATOR WEEKLY (ABOUT 4 APPLICATIONS), TOPICALLY. ON (B)(6) 2024, AFTER USING THE PRODUCT, SHE REPORTED BEING DIAGNOSED WITH A SEVERE URINARY TRACT INFECTION. IN ADDITION, SHE SUFFERED FROM RESPIRATORY SYMPTOMS (CHEST CONGESTION AND COUGH). AFTER THAT, SHE SOUGHT MEDICAL ATTENTION IN THE EMERGENCY ROOM AND WAS PRESCRIBED ANTIBIOTICS (UNSPECIFIED). LATER, SHE STOPPED USING THE PRODUCT. AT THE TIME OF THIS REPORT HER SYMPTOMS HAD PERSISTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH REPLENS VAGINAL MOISTURIZER REUSABLE APPLICATOR WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS WAS NOT RECOVERED.

  Patient problems: Cough; Unspecified Respiratory Problem; Urinary Tract Infection

  MAUDE report 21134579 ↗