Medline Industries, Inc. DYND150816SRecalls & reported problems
Medline Industries, Inc. · TRAY FOL SIL 16FR 10ML W/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
- 11
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10195327149710), received between May 7, 2024 and Sep 18, 2026 — classified as 6 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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
- Fluid/Blood Leak5
- Leak/Splash4
- Device Contamination with Chemical or Other Material1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820342 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756571 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that "leaking Foley report for ICU."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753855 ↗InjuryDec 11, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY ON 11/09/2024, THE FOLEY WAS REMOVED DUE TO LEAKING. IT WAS REPLACED THAT SAME DAY WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903353 ↗InjuryDec 10, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY ON 11/10, THE FOLEY WAS REMOVED DUE TO LEAKING. IT WAS REPLACED THAT SAME DAY WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892642 ↗InjuryNov 19, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY ON (B)(6) 2024 THE FOLEY CATHETER BEGAN LEAKING WHEN THE PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM TO THE INTENSIVE CARE UNIT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20724954 ↗InjuryNov 18, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THERE WAS "GREAT DIFFICULTY" WHILE ATTEMPTING TO INFLATE THE BALLOON AND "SHORTLY AFTER" THE FOLEY BEGAN TO "LEAK".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20714610 ↗InjuryNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY BEGAN TO "LEAK" DESPITE DEFLATING THE BALLOON AND REINFLATING WITH "SALINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20605708 ↗InjuryNov 4, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY, THE CATHETER WAS LEAKING. THE FACILITY STATED THAT THE FOLEY WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 20598425 ↗MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
CATHETER LEAKING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20580660 ↗MalfunctionMay 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN THE FOLEY WAS BEING OPENED A "PARTICULATE WAS FOUND IN SYRINGE" AND AS A RESULT THE ENTIRE KIT WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260222 ↗
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 · 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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