Medline Industries, Inc. DYND04197Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10889942395415), received between Oct 20, 2020 and Sep 24, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Material Fragmentation; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885048 ↗
• InjuryOct 20, 2020Positioning Failure

  IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING.

  Patient problems: Genital Bleeding

  MAUDE report 10706044 ↗
• InjuryOct 20, 2020Positioning Failure

  IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING.

  Patient problems: Genital Bleeding

  MAUDE report 10705480 ↗
• InjuryOct 20, 2020Positioning Failure

  IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING.

  Patient problems: Genital Bleeding

  MAUDE report 10704854 ↗
• InjuryOct 20, 2020Structural Problem

  IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING.

  Patient problems: Genital Bleeding

  MAUDE report 10704646 ↗