X450 M4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560264572645), received between Jul 27, 2026 and Jul 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Gas/Air Leak” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Gas/Air Leak

  On July 8, 2026, Nakanishi became aware of a malfunction of an NSK handpiece through a complaint input into the complaint database by a distributor (NSK America). According to the distributor, there are three handpieces suspected of being involved in the event, but the dental office could not determine which of three handpieces was used during the following event. Therefore, Nakanishi is submitting three separate MDRs for this event. This MDR is regarding the handpiece with the serial number (b)(6).Details are as follows:The event occurred on April 13, 2026. The dentist was performing a dental procedure on a patient using the Ti-Max X450 M4 handpiece (Serial No. (b)(6)). During the procedure, the patient experienced postoperative swelling consistent with air entering the tissue.The swelling experienced by the patient resolved with ice before discharge.Follow-up confirmed there were no lasting complications or need for additional medical treatment.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50065259 ↗
• InjuryJul 27, 2026Gas/Air Leak

  The patient experienced postoperative swelling following a dental procedure consistent with air entering the tissue. The office could not determine which of three handpieces they have was used during the procedure but removed all three from service after observing air blowing outward from each unit. The swelling experienced by the patient resolved with ice before discharge, and follow-up confirmed there were no lasting complications or need for additional medical treatment. This is report 3 of 3 for this issue.(Reference MDR 2026-00028, 2026-00029 for previous reports)

  Patient problems: Air Embolism

  MAUDE report 50047252 ↗