Medline URO2S0803KRecalls & reported problems

Medline Industries, Inc. · 8FR 3ML CATH W/5ML STER WATER · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277561298), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 2/12/2026, THERE WAS AN ORDER PLACED BY THE PA TO REMOVE A FOLEY. 5ML OF SALINE WAS REMOVED FROM THE BALLOON, BUT RESISTANCE WAS FELT WHEN TRYING TO REMOVE THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802679 ↗

Device details

UDI-DI	`10888277561298`
Brand	Medline
Model	URO2S0803K
Company	Medline Industries, Inc.
Product code	OHR · Catheter care tray
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 21, 2019

Device type (GMDN): Surgical irrigation/aspiration handpiece, single-use

A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.