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Henry Schein 5702237Recalls & reported problems

Henry Schein, Inc. · Acclean Easy Grip XL Triple Bend Slim #1000 30K · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00304040165126), received between May 23, 2024 and Aug 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Temperature Problem3

Patient problems

  • Sensitivity of Teeth2
  • Superficial (First Degree) Burn1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2024Temperature Problem; Temperature Problem

    DOCTORS HAND WAS BURNED DURING USE OF DEVICE.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 20006488 ↗
  • MalfunctionMay 31, 2024Temperature Problem; Temperature Problem

    TIP OF PRODUCT GETS HOT AND PRODUCES STEAM. NO PATIENT INJURIES REPORTED.

    Patient problems: Sensitivity of Teeth

    MAUDE report 19432694 ↗
  • MalfunctionMay 23, 2024Temperature Problem; Temperature Problem

    TIP OF PRODUCT GETS HOT AND PRODUCES STEAM. NO PATIENT INJURIES REPORTED.

    Patient problems: Sensitivity of Teeth

    MAUDE report 19386421 ↗

Other Scaler, ultrasonic devices

All Scaler, ultrasonic devices →

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