Tampax Tampax Pearl (UDI 00073010718289)Recalls & reported problems
Procter & Gamble Manufacturing Company, The · Tampax Pearl Ultra · Class 2
All models of Tampax (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00073010718289), received between Mar 30, 2026 and Aug 25, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Insufficient Device Problem Information
"[Tampon]" picked out of the body - vagina "[Foreign body in reproductive tract]". "[Tampon]" disintegrated upon removal and had to be picked out of the body. "[Complication of device removal]". "[Tampon]" disintegrated "[Device breakage]". Case Narrative: Consumer reported via email that the tampon disintegrated during removal. No serious injury was reported.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient
MAUDE report 50426757 ↗MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LOOSE ENDS AND I THINK THEY CAN STAY INSIDE ME..I¿M WORRIED FOR MY HEALTH- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] . THREADS SHREDDING OFF THE TAMPON CORE [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT THERE WERE THREADS SHEDDING OFF THE TAMPON. NO SERIOUS INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 24732645 ↗
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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