Medline Industries, Inc. UROT1076ARecalls & reported problems
Medline Industries, Inc. · TRAY FCMS URNMTR SIL 16FR 10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327391539), received between Sep 15, 2026 and Sep 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Rupture
It was reported that "a nurse attempted to insert a foley catheter on a patient x2 and the balloon burst when inflated."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813091 ↗MalfunctionSep 18, 2026Material Rupture
It was reported that "a nurse attempted to insert a foley catheter on a patient x2 and the balloon burst when inflated."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813083 ↗MalfunctionSep 15, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776086 ↗
Other Foley catheter kit (excludes HIV testing) devices
- Medline Industries, Inc. DYND150200SMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYKE1455BMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ902831DMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ66449Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ36728CMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYKE1350DMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ22890MMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- 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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