Lena LENA-PUR-LRecalls & reported problems
Lena Cup, LLC · A reusable menstrual cup that collects monthly blood flow. · Class 2
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 00850008236068), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Code Available1
- Pain1
- Prolapse1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2020Difficult to Remove; Difficult to Remove
USER REPORTED THAT SHE HAD PAIN WHEN USING THE CUP AND HAS NOTICED A MODERATE INCREASE IN HER CYSTOCELE.
Patient problems: No Code Available; Pain; Prolapse
MAUDE report 10590079 ↗
Other Cup, Menstrual devices
- Flex Reusable Menstrual Disc 10122The Flex Company · Cup, Menstrual26 reports
- Flex Cup and Flex Disc Flex Discovery Kit Slim FitThe Flex Company · Cup, Menstrual6 reports
- Flex Box of Flex 12 count (English only) VERTICALThe Flex Company · Cup, Menstrual6 reports
- Lena LENA-PUR-SLena Cup, LLC · Cup, Menstrual6 reports
- Lena LENA-RED-SLena Cup, LLC · Cup, Menstrual5 reports
- Cora 10MENSTRUALCUP-S1DTCCora · Cup, Menstrual5 reports
- Lena LENA-MIXII-2Lena Cup, LLC · Cup, Menstrual5 reports
- Flex Cup and Flex Disc Flex Discovery Kit Full FitThe Flex Company · Cup, Menstrual4 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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