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VALO 5972Recalls & reported problems

Ultradent Products, Inc. · VALO GRAND CORDLESS CURING LIGHT · Class 2

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 00883205019219), received between Mar 6, 2017 and Mar 6, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Necrosis1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DOCTOR HAS BEEN USING ACTIVA FOR ABOUT 2 YEARS NOW, WITH NO ISSUES. RECENTLY HAD 4 PATIENTS DEVELOP ABSCESSES ASSOCIATED WITH SMALL MO/DO RESTORATIONS PLACED APPROXIMATELY 6 MONTHS AGO. THE ONLY CHANGE IN PROTOCOL WITHIN THE LAST SIX MONTHS IS THE RECENTLY PURCHASED CURING LIGHT. DOCTOR WENT FROM A VALO CORDED TO A VALO CORDLESS GRAND. USED THE CORDLESS ON THE FASTEST (CURING) SETTING DUE TO THE FACT THAT SPEED IS KEY FOR PEDIATRIC PATIENTS. EMAIL CAME IN ASKING IF THERE WERE ANY OUTPUT DIFFERENCES BETWEEN THE CORDED AND THE CORDLESS.

    Patient problems: Necrosis

    MAUDE report 6382979 ↗

Other ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION devices

All ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.