iCare iCare C2 Type (120V)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560264538986), received between May 14, 2026 and May 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, NAKANISHI BECAME AWARE OF DENTAL ASSISTANT INJURY CAUSED BY A HANDPIECE MAINTENANCE UNIT THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2026. A DENTAL ASSISTANT WAS PERFORMING THE CHUCK MAINTENANCE ON THEIR HANDPIECE USING THE ICARE HANDPIECE MAINTENANCE UNIT (SERIAL NO. (B)(6)) BEFORE REPROCESSING. THE ASSISTANT WAS LUBRICATING THE HANDPIECE CHUCK USING THE CHUCK LUBRICATION NOZZLE INCLUDED WITH THE ICARE WHEN THE NOZZLE SHOT OFF THE CONNECTOR UNEXPECTEDLY AND THE TIP OF THE NOZZLE PUNCTURED THE ASSISTANT'S FINGER. THE DENTAL ASSISTANT IS REPORTED TO HAVE HEALED FROM THE INJURY WITHOUT NEED FOR ANY ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25311162 ↗
• InjuryMay 14, 2026Detachment of Device or Device Component

  A DENTAL ASSISTANT SUSTAINED AN INJURY TO THEIR FINGER FROM AN ICARE MAINTENANCE UNIT WHILE PERFORMING THE CHUCK MAINTENANCE ON THEIR HANDPIECE BEFORE REPROCESSING. THE ASSISTANT WAS LUBRICATING THE HANDPIECE CHUCK USING THE CHUCK LUBRICATION NOZZLE INCLUDED WITH THE ICARE WHEN THE NOZZLE SHOT OFF THE CONNECTOR UNEXPECTEDLY AND THE TIP OF THE NOZZLE PUNCTURED THE ASSISTANT'S FINGER. THE DENTAL ASSISTANT IS REPORTED TO HAVE HEALED FROM THE INJURY WITHOUT NEED FOR ANY ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25175281 ↗