IRIS 4323-635Recalls & reported problems
Benco Dental Supply CO. · Iris 5% NAF VARNISH - Mint (200) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 23, 2023Open, Classified
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Z-1697-2023 · Root cause: Employee error · FDA record ↗
Other Varnish, Cavity devices
- Fast Release Varnish 12158M3m Company · 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
- Listerine 00312547235952Kenvue Brands LLC · VARNISH, CAVITY1 report
- Vanish™ 12150L3m Company · VARNISH, CAVITY1 report
- Vanish™ 12150M3m Company · VARNISH, CAVITY1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.