Lena LENA-ORG-SRecalls & 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: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850008236136), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Neuralgia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem
PAIN WITH URINATION AND PAIN IN THE UPPER BACKS OF THIGHS.
Patient problems: Neuralgia
MAUDE report 13516932 ↗

Device details

UDI-DI	`00850008236136`
Brand	Lena
Model	LENA-ORG-S
Company	Lena Cup, LLC
Product code	HHE · Cup, Menstrual
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Menstrual cup/disc, non-latex, reusable

A cup-like or disc-shaped receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is typically removed from the vagina by pulling on a protruding stem/ring or by insertion of a finger to catch its rim. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a reusable device.

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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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