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U by Kotex Tampon (UDI 00036000423402)Recalls & reported problems

Kimberly-Clark Global Sales, Inc. · U BY KOTEX PREMIUM SECURITY TAMPONS REGULAR/SUPER ABSORBENCY MULTIPACK 34 · 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 00036000423402), received between Jun 11, 2021 and Jun 11, 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.

  • MalfunctionJun 11, 2021Material Separation; Material Separation

    CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO REMOVE THE PLEDGET ON HER OWN AND SOUGHT MEDICAL ATTENTION AT URGENT CARE. THE PLEDGET WAS REMOVED AT URGENT CARE AND SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11985003 ↗

Other TAMPON, MENSTRUAL, UNSCENTED devices

All TAMPON, MENSTRUAL, UNSCENTED devices →

Sources and updates

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