Medline Industries, Inc. DYND150100Recalls & reported problems
Medline Industries, Inc. · TRAY ADD A CATH FOLEY DB 10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327387860), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "The bags are leaking just above where the valve connects to the bag. This is when the bag was not overly full and the RN walked in to find urine pooled beneath the Foley drainage bag."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914297 ↗
Other Foley catheter kit (excludes HIV testing) devices
- Medline Industries, Inc. DYND150200SMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
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- 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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