Medline Industries, Inc. DYNJ61294DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489305401), received between Feb 3, 2022 and Sep 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Crack

  It was reported that "Issue here is the stopcock (3 way) threaded part, when they withdraw blood from a port there appears to be a leak in the posterior end of the stopcock that introduces air."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872629 ↗
• MalfunctionSep 9, 2026Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  It was reported that SPT-4124 DRAPE TRANSRADIAL 86 X 148 has been difficult to unfold and is sticking to itself.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693779 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305587 ↗
• MalfunctionAug 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256375 ↗
• MalfunctionMar 26, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT, ACCORDING TO A PROCEDURAL TECH, AIR LEAKED INTO A CONTROL SYRINGE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978291 ↗
• InjuryFeb 3, 2022Break

  THE FACILITY REPORTED THAT THE GUIDE WIRE WITHIN THE PACK "SHREDDED" INSIDE THE PATIENT. NO ADDITIONAL DETAILS WERE PROVIDED RELATED TO THE CUSTOMER REPORTED ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13441855 ↗