Fast Release Varnish 12158SRecalls & reported problems
3m Company · 3M™ ESPE™ Fast Release Varnish, Strawberry, 200 Pack, 12158S · Class 2
All models of Fast Release Varnish (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30605861060678), received between Jan 28, 2022 and Nov 21, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Human-Device Interface Problem1
Patient problems
- Burning Sensation1
- Erythema1
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2023Human-Device Interface Problem; Human-Device Interface Problem
AN ALLERGIC REACTION (SYMPTOMS UNSPECIFIED) WAS REPORTED WITH 3M¿ FAST RELEASE 5% SODIUM FLUORIDE VARNISH, STRAWBERRY FLAVOR. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18185726 ↗InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SWELLING OF THE LIP, REDNESS OF THE TONGUE AND BURNING SENSATION THROUGHOUT THE BODY WAS ALLEGED THE MORNING AFTER APPLICATION OF 3M FAST RELEASE VARNISH, 5% SODIUM FLUORIDE, STRAWBERRY FLAVOR. THE SWELLING CONTINUED THE NEXT FEW DAYS, INCLUDING THE HANDS. THE DENTIST PRESCRIBED PREDNISONE (6- DAY CYCLE), AFTER WHICH THE SYMPTOMS REDUCED BUT CONTINUED. THE PATIENT PLANNED ON SEEING A DERMATOLOGIST. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Burning Sensation; Erythema; Swelling/ Edema
MAUDE report 13389270 ↗
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
- Varnish Pen - Assorted 295782Young Dental Manufacturing I, LLC · Varnish, Cavity1 report
- Listerine 00312547235952Kenvue Brands LLC · VARNISH, CAVITY1 report
- Vanish™ 12150M3m Company · 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.
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