Medline URO170808TRecalls & reported problems
Medline Industries, Inc. · TRAY, 1LYR 8FR 3ML100%SIL TEMP URN MTR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942929177), received between Feb 11, 2026 and Sep 9, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Leak/Splash1
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.
MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697266 ↗MalfunctionFeb 11, 2026Leak/Splash
ACCORDING TO THE FACILITY, THE NURSE "DISCOVERED TEMP PROBE ON FOLEY CATHETER WAS LEAKING URINE ONTO THE CHUX PAD IN PATIENT'S CRIB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318946 ↗
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- 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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