Medline Industries, Inc. URO175200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10193489987676), received between Oct 15, 2025 and Sep 18, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823125 ↗
• MalfunctionJan 12, 2026Device Dislodged or Dislocated

  BROKEN SAMPLE PORT.

  Patient problems: Insufficient Information

  MAUDE report 24036380 ↗
• MalfunctionJan 2, 2026Connection Problem

  SAMPLE PORT BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 23944880 ↗
• MalfunctionDec 18, 2025Break; Break

  ACCORDING TO THE CUSTOMER, 11/16/2025 THE "SAMPLE PORT [CAME OFF] OF AN ADD-A-CATH" AND A NEW "FOLEY AND ADD A CATH KIT WAS REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839412 ↗
• MalfunctionDec 1, 2025Disconnection; Connection Problem; Disconnection; Connection Problem

  ACCORDING TO THE FACILITY, THE FOLEY CATHETER BECAME DISCONNECTED FROM THE FOLEY BAG.

  Patient problems: Insufficient Information

  MAUDE report 23689382 ↗
• MalfunctionDec 1, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE FACILITY, "ACCESS PORT ON FOLEY CATHETER WHERE YOU CAN PULL OFF URINE FOR LABS BROKE OFF."

  Patient problems: Insufficient Information

  MAUDE report 23689381 ↗
• MalfunctionDec 1, 2025Disconnection; Disconnection

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE CUSTOMER REPORTED THAT THE "FOLEY CATHETER CAME DISCONNECTED FROM BAG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687088 ↗
• InjuryDec 1, 2025Disconnection; Disconnection

  DURING PATIENT REPOSITIONING, THE FOLEY CATHETER BECAME DISCONNECTED FROM THE DRAINAGE BAG. THE FOLEY CATHETER AND DRAINAGE BAG WERE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686164 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  PORT BROKE OFF FOLEY CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 23680795 ↗
• InjuryNov 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON (B)(6) 2025, THE PATIENT HAD AN INDWELLING CATHETER THAT WAS DISCOVERED TO BE DISCONNECTED FROM THE FOLEY BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618511 ↗
• InjuryNov 18, 2025Connection Problem; Connection Problem

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE CUSTOMER REPORTED THAT THE "FOLEY WAS DISCONNECTED FROM THE DRAINAGE BAG." THE CUSTOMER REPORTED THAT THEIR PROCESS IS TO "CHANGE OUT THE FOLEY AND BAG IF IT BECOMES DISCONNECTED."

  Patient problems: Insufficient Information

  MAUDE report 23582713 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  SAMPLE PORT BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302177 ↗