Medline DYND140214Recalls & reported problems

Medline Industries, Inc. · TRAY,FOLEY,SILVER,2-WAY,14FR,10ML,LF · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196183012), received between Jun 24, 2024 and Jun 25, 2024 — classified as 2 injuries.

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.

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 Available2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJun 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO FACILITY THE FOLEY CATHETER WAS PLACED AND "THE PATIENT WAS ABLE TO URINATE AROUND FOLEY APPROXIMATELY 1 MINUTE AFTER PLACEMENT, SUBSEQUENTLY THE FOLEY FELL OUT AND WAS REPLACED WITH ANOTHER FOLEY KIT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605305 ↗
InjuryJun 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO FACILITY THE FOLEY CATHETER WAS PLACED AND "THE PATIENT WAS ABLE TO URINATE AROUND FOLEY APPROXIMATELY 1 MINUTE AFTER PLACEMENT, SUBSEQUENTLY THE FOLEY FELL OUT AND WAS REPLACED WITH ANOTHER FOLEY KIT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19597047 ↗

Device details

UDI-DI	`10080196183012`
Brand	Medline
Model	DYND140214
Company	Medline Industries, Inc.
Product code	EYZ · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
Class	Class 1
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	Dec 4, 2020

Device type (GMDN): Indwelling urethral catheterization kit, adult

A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Other SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE devices

Medline DYND10820
Medline Industries, Inc. · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
2 reports
Medline DYND140218
Medline Industries, Inc. · SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
2 reports

All SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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