Medline Industries, Inc. DYND150216SRecalls & reported problems
Medline Industries, Inc. · TRAY FOLEY LTX 16FR 10ML UM MF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327387365), received between Oct 4, 2024 and Sep 9, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 4, 2024Class IIOpen, Classified
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Z-0164-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Distress1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699521 ↗MalfunctionNov 1, 2024Inflation Problem; Inflation Problem
BALLOON FAILED TO INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20587229 ↗InjuryOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE FACILITY, ON 8/12 "THE INDWELLING URINARY CATHETER PLACED IN 87 YEAR OLD MALE PATIENT. UPON ENTRANCE INTO THE BLADDER, URINE STREAM WAS NOTED TO BE SPRAYING OUT OF A PREVIOUSLY NOT VISIBLE PINHOLE IN THE CATHETER ITSELF."
Patient problems: Distress
MAUDE report 20371256 ↗
Other Foley catheter kit (excludes HIV testing) devices
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- 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 · each recall links to the FDA recall notice
- 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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