Medline Industries, Inc. URO170216CQRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489894240), received between Nov 12, 2025 and Sep 21, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838787 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that "RN removed syringe and the entire injection port dislodged and allowed chemotherapy/urine to pour out of the opening resulting in a chemotherapy spill. This is the second failure in a weeks time."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754839 ↗
• MalfunctionSep 14, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

  It was reported that, "Sample port dislodged from catheter while syringe attached, causing urine to pour from opening."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754818 ↗
• InjuryNov 12, 2025Break; Break

  ACCORDING TO THE CUSTOMER, AFTER ADMINISTERING "CHEMOTHERAPY" THROUGH THE INJECTION PORT, "THE ENTIRE INJECTION PORT DISLODGED AND ALLOWED CHEMOTHERAPY/URINE TO POUR OUT OF THE OPENING RESULTING IN A CHEMOTHERAPY SPILL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534255 ↗