NA 5100337233Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540075444), received between Jun 17, 2019 and Oct 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY RECEIVED IN SUCH A MANNER TO INDICATE THAT ITS STERILITY HAD BEEN COMPROMISED. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504578 ↗
• MalfunctionMar 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, DURING PREPARATION FOR A SURGERY, A HAIR WAS IDENTIFIED IN THE PACKAGING. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698073 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT ON RECEIPT OF THE BLADE, THE BLADE WAS BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8703575 ↗