Medline Industries, Inc. DYKE1412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889942460557), received between Sep 10, 2026 and Sep 28, 2026 — classified as 4 malfunctions.

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

• MalfunctionSep 28, 2026Fluid/Blood Leak

  It was reported that "MULTIPLE ENDO KITS HAVE BEEN DLVRD AND WET INSIDE THE PACKAGING" and the "ISSUE CONTINUES TO HAPPEN ON MULTIPLE LOT NUMBERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916209 ↗
• MalfunctionSep 25, 2026Microbial Contamination of Device

  It was reported that "mold and leaking."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896633 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722123 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  It was reported that "The whole case of 9 were leaking" and "the bedside cleaning kit has rupture inside the bag and has soiled the rest of the individual packaged kit."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714591 ↗