Fast Release Varnish 12158MRecalls & reported problems
3m Company · 3M™ ESPE™ 12158M FAST RELEASE VARNISH MINT 200PK · Class 2
All models of Fast Release Varnish (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jul 6, 2018Class IITerminated
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Z-0368-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Other VARNISH, CAVITY devices
- 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
- Fast Release Varnish 12158S3m Company · VARNISH, CAVITY2 reports
- MEDICOM DURAFLOR HALO 1015-WB32 PK6AMD Medicom Inc · VARNISH, CAVITY2 reports
- Varnish Pen - Assorted 295782Young Dental Manufacturing I, LLC · Varnish, Cavity1 report
- Vanish™ 12150M3m Company · VARNISH, CAVITY1 report
- Darby Dental Supply, LLC 9430600Darby Dental Supply, 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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