Medline Industries, Inc. URO175814SRecalls & reported problems
Medline Industries, Inc. · 1LYRTR 14FR10ML100%SIL UMS SNP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489988291), received between Jul 29, 2025 and Sep 15, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
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 15, 2026Crack
It was reported that "when urine dumped from meter to bag leaking occurred and noticed crack along the back side of urine meter and around corner."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777432 ↗InjuryJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, THE "URINE METER BAG" WAS "LEAKING" REQUIRING CATHETER REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644058 ↗
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- Medline Industries, Inc. DYKE1721Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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