Medline DYND12578Recalls & reported problems
Medline Industries, Inc. · BAG,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ · 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10080196990320), received between Apr 27, 2026 and Sep 21, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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
- Oct 19, 2023Class IIOpen, Classified
Undeclared latex
Z-0534-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak6
- Material Puncture/Hole2
- Detachment of Device or Device Component1
- Difficult to Open or Close1
- Leak/Splash1
- Material Separation1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Unintended Movement
It was reported that "THE TWIST VALVE WON'T STAY CLOSED. WHEN WEARING IT, THE VALVE STARTS TO OPEN DUE TO FRICTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846192 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840660 ↗MalfunctionSep 21, 2026Material Separation; Difficult to Open or Close
It was reported that one leg bag - little valve at the bottom that drains, would not close, the other one the seam opened up.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840199 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821032 ↗MalfunctionSep 18, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported that THE LEG BAGS RECEIVED LEAK AND HAVE VISUAL HOLES ON THE INSIDE OF THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819021 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
It was reported that "BAG IS LEAKING FROM THE SEAMS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793052 ↗MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676501 ↗MalfunctionSep 8, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671822 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that "they leaked where the valve attaches to the plastic."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485628 ↗MalfunctionApr 27, 2026Leak/Splash
CUSTOMER REPORTED, "BAG WAS LEAKING, THREW AWAY."
Patient problems: Insufficient Information
MAUDE report 25009168 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
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- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
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- 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 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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