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U by Kotex Tampon (UDI 00036000423372)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 00036000423372), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (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

  • Device Fell1
  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 5, 2019Manufacturing, Packaging or Shipping Problem; Device Fell

    KOTEX U REGULAR (NON-SLIM) TAMPON MANUFACTURER DEFECT. WHEN REMOVING A TAMPON THIS MORNING, A PIECE (APPROX 1 INCH) OF A TAMPON FELL INTO THE TOILET. THE PIECE MAY BE FROM A DAY OR TWO AGO. THIS IS A NON-SLIM REGULAR TAMPON.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8310645 ↗

Other TAMPON, MENSTRUAL, UNSCENTED devices

All TAMPON, MENSTRUAL, UNSCENTED devices →

Sources and updates

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