tropicalgin C302240Recalls & reported problems
Zhermack SPA · Alginate impression material · 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 EZHIC3022400), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
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.
InjuryJan 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT TROPICALGIN ALGINATO BUSTA 453G. USE FOR IMPRESSIONS, PATIENT COMPLAINED OF BURNING SENSATION, FEELING HEAT AND REDNESS ON THE TONGUE. FURTHER INFORMATION REQUESTED. ALLERGIC REACTION CHECKLIST WAS SENT FOR CUSTOMER TO COMPLETE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21228350 ↗
Other MATERIAL, IMPRESSION devices
- Affinity™ Heavy Body RS 12pk 013912Clinician'S Choice Dental Products, Inc. · MATERIAL, IMPRESSION1 recall0 reports
- Jeltrate® Dustless Alginate Impression Material 605224Dentsply International Inc. · MATERIAL, IMPRESSION19 reports
- Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material 605700Dentsply International Inc. · MATERIAL, IMPRESSION7 reports
- Impression Kit StandardStraight Smile LLC · Material, Impression4 reports
- neocolloid C302205Zhermack SPA · MATERIAL, IMPRESSION2 reports
- Aquasil® Ultra+ Smart Wetting® Impression Material 678684Dentsply International Inc. · MATERIAL, IMPRESSION1 report
- Express™ 73123m Company · MATERIAL, IMPRESSION1 report
- hydrogum C302025Zhermack SPA · MATERIAL, IMPRESSION1 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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