UNIUM 05.001.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 10886982309549), received between Jan 18, 2022 and Sep 30, 2026 — classified as 339 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (136 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Detachment of Device or Device Component

  It was reported that the coupling of the handpiece device was defective. During in-house engineering evaluation it was determined that the protective heat cover fell off the handpiece and was missing. This event did not occur during surgery. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951778 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951278 ↗
• MalfunctionSep 28, 2026Component Missing

  It was reported that during service and evaluation, it was determined that the modular handpiece device had missing components. It was noted in the service order that the device was missing a ring. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914843 ↗
• MalfunctionSep 28, 2026Component Missing

  It was reported that during service and repair pre-testing, it was discovered that the modular handpiece device had missing components. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914674 ↗
• MalfunctionSep 21, 2026Noise, Audible; Intermittent Loss of Power

  It was reported that the oscillating function of the handpiece device continued to operate intermittently after use, accompanied by abnormal noise. It was not reported if the device was used in a surgical procedure. There was no human patient involvement as this was a veterinary procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838549 ↗
• MalfunctionSep 18, 2026Unintended System Motion

  It was reported that during an unspecified surgery, the oscillation mode on the UNIUM¿ MODULAR HANDPIECE device would partially activate when activated normally. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823783 ↗
• MalfunctionSep 18, 2026Device Slipped

  It was reported that while using the UNIUM MODULAR HANDPIECE device, when a command was activated on the equipment it triggered a different command. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818717 ↗
• MalfunctionSep 17, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810110 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808658 ↗
• MalfunctionSep 17, 2026Noise, Audible; Intermittent Loss of Power

  It was reported that during pre-surgery testing it was observed that, after attaching the K-wire attachment to the handpiece device, there was a metal grinding noise during operation. It was further observed that the handpiece device briefly stopped working and then automatically resumed working. It was reported that there was no delay in the procedure due to the event. There were no reports of injuries, medical There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802114 ↗
• MalfunctionSep 16, 2026Physical Resistance/Sticking

  It was reported that during product maintenance it was observed that the reverse button on the handpiece device could not be completely pressed. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787248 ↗
• MalfunctionSep 15, 2026Break; Mechanical Jam; Physical Resistance/Sticking

  It was reported that during an unspecified surgical procedure it was observed that the upper trigger of the handpiece device was broken, and the reverse mode could not be used. It was reported that the upper trigger would not fully press down, making it difficult to use the reverse function. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770971 ↗
• MalfunctionSep 14, 2026Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power

  It was reported that during testing, the UNIUM MODULAR HANDPIECE device trigger pulled on its own. What happened was that the oscillate function would activate on its own, very intermittently. There was a problem with the seals in the triggers. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754465 ↗
• MalfunctionSep 11, 2026Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740665 ↗
• MalfunctionSep 3, 2026Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595114 ↗
• MalfunctionAug 28, 2026Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497234 ↗
• MalfunctionAug 26, 2026Mechanical Jam

  It was reported that during service and evaluation, it was determined that the UNIUM MODULAR HANDPIECE device trigger moving parts did not move smoothly. It was noted in the service order that the device would not operate in reverse mode. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451833 ↗
• MalfunctionAug 25, 2026Fail-Safe Did Not Operate

  It was reported that during service and repair pre-testing, it was discovered that the modular handpiece device ran in locked position. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436982 ↗
• MalfunctionAug 25, 2026Output below Specifications; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430748 ↗
• MalfunctionAug 17, 2026Device Slipped

  It was reported that during an unspecified veterinary surgical procedure it was observed that when the handpiece device was in FORWARD mode, it would randomly oscillate. It was reported that there was no delay in the procedure due to the event. It was not reported if a spare device was available for use. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276655 ↗
• MalfunctionAug 6, 2026Complete Loss of Power; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166035 ↗
• MalfunctionAug 6, 2026Component Missing; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164751 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024910 ↗
• MalfunctionJul 27, 2026Component Missing; Output below Specifications; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012461 ↗
• MalfunctionMay 12, 2026Complete Loss of Power; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE UNIUM MODULAR HANDPIECE DEVICE HAD UNEXPECTED DISENGAGEMENT - BATTERY/CASE/LID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WOULD NOT TURN ON. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152686 ↗