Medline DYND12574Recalls & reported problems
Medline Industries, Inc. · BAG,LEG,TWIST-VALVE,STRAPS,MEDIUM,20OZ · Class 1
Data updated Oct 16, 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
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10080196990337), received between May 17, 2026 and Sep 30, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 16, 2026.
Reports received per month
Recalls naming this device
- Oct 19, 2023Open, Classified
Undeclared latex
Z-0533-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak11
- Mechanical Problem2
- Component Missing1
- Connection Problem1
- Detachment of Device or Device Component1
- Difficult to Open or Close1
- Leak/Splash1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951583 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
It was reported that "he connects the bag, then when he gets up the urine drips out of the emptying valve without the valve being open."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898620 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892636 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that he connects the bag, then when he gets up the urine drips out of the emptying valve without the valve being open.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869132 ↗MalfunctionSep 22, 2026Mechanical Problem
It was reported that "SO FAR TWO BAGS WILL NOT CLOSE TIGHTLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858424 ↗MalfunctionSep 22, 2026Fluid/Blood Leak; Loose or Intermittent Connection
It was reported that "2 COUNT TWIST VALVE WON'T STAY TIGHT, LEASKS, VERY LOOSE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853871 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845728 ↗MalfunctionSep 21, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842643 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that the unit was leaking and it was being used and saw there was leakage. Unsure of where but they think it was on the side of the bag.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840571 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820748 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756003 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that "His urine is not holding in the bag" It was also reported that "the leg bags are glued together."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752478 ↗MalfunctionSep 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746711 ↗MalfunctionSep 11, 2026Fluid/Blood Leak; Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737283 ↗MalfunctionMay 17, 2026Leak/Splash
PER EMAIL, CUSTOMER FILED COMPLAINT OF LEG BAG LEAKING.
Patient problems: Insufficient Information
MAUDE report 25196852 ↗
Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices
- Leg Bag 150819C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE102 reports
- Leg Bag 150832C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE100 reports
- Leg Bag 150719C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150732C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150632C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE18 reports
- Leg Bag 150419C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE15 reports
- Leg Bag 151932C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE7 reports
- Leg Bag 150432C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE6 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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