Listerine 00312547235952Recalls & reported problems
Kenvue Brands LLC · LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 95 ML · 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 00312547235952), received between Aug 8, 2025 and Aug 8, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anaphylactoid / Anaphylaxis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CONSUMER & APOS'S DAUGHTER REPORTED AN ADVERSE EVENT WITH LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 95ML. CONSUMER & APOS'S DAUGHTER REPORTED VIA SOCIAL MEDIA THAT HER MOTHER HAD A BALLOON BLOWN UP IN HER ESOPHAGUS DUE TO THE ALLERGIC REACTION IN HER THROAT FROM USING THE REPORTED PRODUCT AND WAS TREATED FOR PROBLEMS (ANAPHYLAXIS). THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO THE EVENT FOR THIS CONSUMER.
Patient problems: Anaphylactoid / Anaphylaxis
MAUDE report 22747927 ↗
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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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