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EFAClass 1

Handpiece, Belt And/Or Gear Driven, Dental

FDA adverse event reports and recall history for handpiece, belt and/or gear driven, dental (product code EFA), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
218
Deaths
0
Injuries
32
Malfunctions
184

Reports per year

07
08
10
11
12
16
17
18
19
20
22
23
24
25
26

Source: FDA adverse event reports by year received, 20072026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2014-07-17TerminatedProcess control

    Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.

    The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.

  • 2010-09-02TerminatedLabeling mix-ups

    Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free

    The housing of 5K motor is labeled as a 20K motor.

  • 2006-12-27TerminatedOther

    Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.

    End cap component can disassemble.

Monitor handpiece, belt and/or gear driven, dental automatically

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