OB 02179Recalls & reported problems
Edgewell Personal Care Brands, LLC · 40CT o.b. HELIX ULTRA 4/3 (US/CN) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300021797), received between Aug 28, 2026 and Aug 28, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Unraveled Material1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Material Fragmentation; Unraveled Material
The consumer stated they thought the tampons had changed. They found the tampons to feel hard and painful when they used to feel comfortable. The consumer indicated they had been finding that the tampons unravel upon removal. In this instance the consumer stated the tampon unraveled upon removal and they were visiting a doctor to assist with the removal of a piece of tampon retained in their body. The consumer noted they believed the retained piece was causing an infection. Upon visiting the OB-GYN the consumer indicated fibers were removed and antibiotics were prescribed.
Patient problems: Unspecified Infection
MAUDE report 50500182 ↗
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
- Daye FG-TMP-MM-IB18180000Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-RET09000900Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-MM-REF18180000Tampon 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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