U By KotexRecalls & reported problems across all models
Kimberly-Clark Global Sales, Inc. · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 855
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 3
We found 42 models of U By Kotex by Kimberly-Clark Global Sales, Inc. in the FDA's device registry (GUDID). Together they are named in 855 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2018 and Sep 23, 2026 — classified as 2 injuries, 853 malfunctions.
The most frequently reported specific device problem is “Material Separation” (656 reports).
3 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
U By Kotex recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 11, 2018Terminated
Potential for tampon to come apart upon removal.
Z-0750-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 11, 2018Terminated
Potential for tampon to come apart upon removal.
Z-0749-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 11, 2018Terminated
Potential for tampon to come apart upon removal.
Z-0748-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported U By Kotex problems
Device problems
- Material Separation656
- Break79
- Difficult to Remove67
- Product Quality Problem29
- Component Missing25
- Defective Component10
- Difficult to Insert8
- Sharp Edges3
Patient problems
- No Clinical Signs, Symptoms or Conditions549
- No Consequences Or Impact To Patient78
- Insufficient Information66
- Pain52
- Discomfort32
- Foreign Body In Patient31
- Cramp(s) /Muscle Spasm(s)15
- Abdominal Cramps11
U By Kotex models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented178 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented126 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented126 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 recall2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 recall1 report
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented50 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented48 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented46 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented45 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented41 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented34 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented30 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented21 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED16 reports
- U By Kotex TamponTampon, menstrual, unscented10 reports
- U By Kotex TamponTampon, menstrual, unscented10 reports
- U By Kotex TamponTampon, menstrual, unscented8 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED7 reports
- U By Kotex TamponTampon, menstrual, unscented7 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented6 reports
- U By Kotex TamponTampon, menstrual, unscented5 reports
- U By Kotex TamponTampon, menstrual, unscented4 reports
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented4 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED3 reports
- U By Kotex TamponTampon, menstrual, unscented3 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED2 reports
- U By Kotex TamponTampon, menstrual, unscented2 reports
- U By Kotex TamponTampon, menstrual, unscented2 reports
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U by Kotex TamponTAMPON, MENSTRUAL, UNSCENTED1 report
- U By Kotex TamponTampon, menstrual, unscented1 report
- U By Kotex KOTEX TAMPONSTampon, menstrual, unscented1 report
Recent U By Kotex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Material Separation
Consumer reported on behalf of her daughter that with an unspecified number of tampons, the string separated from the pledget during removal. In all but one case, she was able to manually remove the pledget from her vaginal cavity. With the other case, she went to the emergency room for removal. She did not experience any serious adverse events.
Patient problems: Foreign Body In Patient
MAUDE report 50869629 ↗MalfunctionSep 22, 2026Break
Non-US event; occurred in Canada. Consumer reported upon removal of a Regular absorbency tampon, the string broke. She manually removed the pledget from her vaginal cavity. She did not seek medical attention and she did not report any adverse health effects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854992 ↗MalfunctionSep 1, 2026Material Separation
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50543114 ↗MalfunctionSep 1, 2026Material Separation
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50543024 ↗MalfunctionAug 26, 2026Component Missing
Consumer reported upon attempted removal of a tampon, the string was missing. She received assistance from her husband to manually remove the pledged from her vaginal cavity. She did not seek medical attention, and she did not experience any adverse health effects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452723 ↗MalfunctionAug 13, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233827 ↗MalfunctionAug 10, 2026Component Missing
Consumer reported on behalf of his wife that upon removal of a tampon from her vaginal cavity, the string was missing. She was able to manually remove the pledget. She did not seek medical attention and did not experience any adverse health effects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195021 ↗MalfunctionAug 6, 2026Difficult to Remove
Patient problems: Foreign Body In Patient
MAUDE report 50164888 ↗MalfunctionAug 6, 2026Material Separation
Patient problems: Foreign Body In Patient
MAUDE report 50155893 ↗MalfunctionJul 21, 2026Material Separation
Patient problems: Insufficient Information
MAUDE report 25889097 ↗MalfunctionJul 1, 2026Break
CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE STRING FROM A TAMPON BROKE. SHE ALLEGED SEEKING UNSPECIFIED MEDICAL SERVICES TO HAVE THE PLEDGET REMOVED. NO SYMPTOMS WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 25677743 ↗MalfunctionJun 15, 2026Difficult to Remove
CONSUMER REPORTED VIA EMAIL THAT UPON REMOVAL OF A TAMPON, SHE REALIZED THE STRING WAS SHORT AND SHE HAD TO SEARCH FOR IT TO REMOVE THE PLEDGET. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS AND DID NOT REQUIRE MEDICAL ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504236 ↗MalfunctionJun 1, 2026Material Separation
REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348226 ↗MalfunctionJun 1, 2026Material Separation
REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348184 ↗MalfunctionMay 20, 2026Material Separation
NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT THE STRING FROM A REGULAR ABSORBENCY TAMPON SEPARATED FROM THE PLEDGET. SHE AND HER PARTNER WERE UNSUCCESSFUL AT REMOVING THE PLEDGET FROM HER VAGINAL CAVITY SO 24 HOURS LATER SHE HAD IT REMOVED AT A MEDICAL CLINIC. SHE EXPERIENCED AN IRRITATION AND BURNING SENSATION INSIDE, WHICH HAS SINCE IMPROVED. SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS. .
Patient problems: Burning Sensation; Foreign Body In Patient; Skin Inflammation/ Irritation
MAUDE report 25229287 ↗
Other Kimberly-Clark Global Sales, Inc. products
All Kimberly-Clark Global Sales, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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