Vanish™ 12150MRecalls & reported problems
3m Company · 3M™ ESPE™ Vanish™ 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate (TCP) 100 Pack - Mint Flavor, 12150M · Class 2
Data updated Oct 16, 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 30605861013179), received between Aug 15, 2025 and Aug 15, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S MOTHER REPORTED HER SON WENT INTO ANAPHYLACTIC SHOCK AFTER APPLICATION OF 3M¿ VANISH¿ 5% SODIUM FLUORIDE WHITE VARNISH, WAS SEEN AT THE EMERGENCY ROOM (ER), REQUIRED TREATMENT WITH EPINEPHRINE, AND IS NOW BETTER. THE DENTAL OFFICE¿S PATIENT COORDINATOR LATER REPORTED NUPRO® PROPHYLACTIC PASTE WITH FLUORIDE WAS ALSO APPLIED DURING THE DENTAL APPOINTMENT PRIOR TO THE VARNISH. THE PATIENT WAS SEEN AT THE ER APPROXIMATELY ONE HOUR LATER DUE TO A RASH ON THE FACE, RECEIVED EPINEPHRINE, AND WAS RELEASED FROM THE ER THAT SAME DAY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 22821877 ↗
Other VARNISH, CAVITY devices
- Fast Release Varnish 12158M3m Company · VARNISH, CAVITY1 recall0 reports
- IRIS 4323-635Benco Dental Supply CO. · Varnish, Cavity1 recall0 reports
- Philips Zoom! Chairside Light-Activated Whitening Kit DIS556Discus Dental, LLC · VARNISH, CAVITY8 reports
- Philips Zoom! Chairside Light-Activated Whitening Kit DIS557Discus Dental, LLC · VARNISH, CAVITY7 reports
- MEDICOM DURAFLOR HALO 1015-WB32 PK6AMD Medicom Inc · VARNISH, CAVITY2 reports
- Fast Release Varnish 12158S3m Company · VARNISH, CAVITY2 reports
- Varnish Pen - Assorted 295782Young Dental Manufacturing I, LLC · Varnish, Cavity1 report
- Listerine 00312547235952Kenvue Brands LLC · VARNISH, CAVITY1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page