U By Kotex Tampon (UDI 00036000515756)Recalls & reported problems
Kimberly-Clark Global Sales, Inc. · U BY KOTEX PREMIUM SECURITY TAMPONS SUPER PLUS 45 · Class 2
All models of U By Kotex (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00036000515756), received between Oct 15, 2020 and Sep 10, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Difficult to Remove1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
- Discomfort1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Difficult to Remove; Difficult to Remove
CONSUMER REPORTED THE STRING WAS CAUGHT UP IN THE INSERTION TUBE BUT SHE INSERTED THE TAMPON ANYWAY AND UPON REMOVAL WAS UNABLE TO FIND THE STRING. AFTER WEARING THE TAMPON 30 MINUTES SHE WAS UNCOMFORTABLE DUE TO THE TAMPON BEING INSERTED TOO LOW. UPON REMOVAL SHE COULD NOT FIND THE STRING AND HAD TO MANUALLY REMOVE THE PLEDGET. THE STRING WAS ATTACHED TO THE PLEDGET BUT HAD BEEN INSIDE HER ALONG WITH THE PLEDGET. SHE STATED SHE FELT LIKE HER VAGINAL WALL EXPANDED AS SHE REMOVED THE PLEDGET. THE DISCOMFORT RESOLVED AND SHE DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.
Patient problems: Discomfort
MAUDE report 12456135 ↗MalfunctionNov 13, 2020Material Separation; Material Separation
CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY FOUR HOURS AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES OF TAMPON AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10837049 ↗MalfunctionOct 15, 2020Component Missing; Component Missing
CONSUMER REPORTED MULTIPLE TAMPONS IN THE BOX DID NOT HAVE A STRING. SHE DISCARDED THE TAMPONS AND DID NOT USE THEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10687574 ↗
Other Tampon, menstrual, unscented devices
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented178 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall2 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall1 report
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- Daye FG-TMP-REF00090009Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-RET00090009Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
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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