Medline UROT1098Recalls & reported problems
Medline Industries, Inc. · TOTAL TRAY 14FR 10ML SIL FOLEY · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489491074), received between Jun 28, 2022 and Sep 11, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Integrity Problem2
- Detachment of Device or Device Component1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744616 ↗MalfunctionAug 5, 2024Material Integrity Problem; Material Integrity Problem
DETACHED SAMPLE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905903 ↗MalfunctionAug 5, 2024Material Integrity Problem; Material Integrity Problem
DETACHED SAMPLE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905458 ↗MalfunctionJun 28, 2022Break
IT WAS REPORTED BY THE FACILITY THAT THE FOLEY CATHETER BALLOON BROKE ON INFLATION WHILE IN THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14848803 ↗InjuryJun 28, 2022Break
IT WAS REPORTED BY THE FACILITY THAT THE FOLEY CATHETER BALLOON BROKE ON INFLATION WHILE IN THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14847329 ↗InjuryJun 28, 2022Break
IT WAS REPORTED BY THE FACILITY THAT THE FOLEY CATHETER BALLOON BROKE ON INFLATION WHILE IN THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14847317 ↗
Other Catheter care tray devices
- Medline Industries, Inc. DYNJ81597Medline Industries, Inc. · Catheter care tray2 recalls0 reports
- Centurion Medical Products Corp CVI680CMedline Industries, Inc. · Catheter care tray2 recalls0 reports
- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- Centurion Medical Products Corp IVS3635BMedline Industries, Inc. · Catheter care tray1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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