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U by Kotex Tampon (UDI 00036000150636)Recalls & reported problems

Kimberly-Clark Global Sales, Inc. · U BY KOTEX PREMIUM SECURITY REGULAR ABSORBENCY TAMPONS · Class 2

All models of U By Kotex (42)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00036000150636), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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

Device problems

  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 23, 2021Material Separation; Material Separation

    CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET IN ONE PIECE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12862171 ↗

Other TAMPON, MENSTRUAL, UNSCENTED devices

All TAMPON, MENSTRUAL, UNSCENTED devices →

Sources and updates

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