Perifix® 332254Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964178788), received between Jun 26, 2020 and Jan 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: UPON OPENING THE PRODUCT, IT WAS OBSERVED THAT A LONG PIECE OF HAIR WAS WRAPPED ON THE APPLICATOR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188455 ↗
• MalfunctionJun 26, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE NEEDLE BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199706 ↗
• MalfunctionJun 26, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE NEEDLE BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199704 ↗
• MalfunctionJun 26, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE NEEDLE BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199476 ↗