Medline DYND15207Recalls & reported problems
Medline Industries, Inc. · BAG,DRAINAGE,ANTI-REFLUX DEVICE,2000ML · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196446018), received between May 5, 2026 and Sep 21, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak7
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that bags are leaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838077 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778927 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746175 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699054 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
It was reported that ¿QTY 1 EA 6015207 DYND15207 leaked at side seam.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694033 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
It was reported that BAGS RECEIVED DEFECTIVE CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692868 ↗MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671104 ↗MalfunctionMay 5, 2026Leak/Splash
PER EMAIL, "TOP OF THE BAG WHERE THE HOSE GOES INTO THE MAIN DRAINAGE BAG THE URINE IS LEAKING FROM THE HOLE. THE HOLE IS NOT SEALED PROPERLY AND IS CAUSING LEAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088338 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER117 reports
- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.