MEDLINE DYND19124Recalls & reported problems
Medline Industries, Inc. · SET,IRRIGATION,4-LEAD,90 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196993833), received between Feb 2, 2023 and Sep 23, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Disconnection” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection3
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Disconnection
It was reported that "The issue is that the when the tubing connects with the cystoscope, our tubing is not staying on and is blowing out."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868786 ↗MalfunctionSep 18, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829654 ↗MalfunctionSep 14, 2026Disconnection; Fluid/Blood Leak
It was reported that "The tubing keeps slipping off the stop cock and water is spraying out while the surgeon is using it."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752559 ↗MalfunctionFeb 2, 2023Infusion or Flow Problem; Material Deformation
MEDLINE TUBING KEPT KINKING AND INTERRUPTED FLOW OF FLUIDS NEEDED FOR THE SURGERY, EXTENDING DURATION OF SURGERY.
Patient problems: Insufficient Information
MAUDE report 16283405 ↗
Other System, irrigation, urological devices
- MED-RX 10-4001Canadian Hospital Specialties Limited · System, Irrigation, Urological1 recall0 reports
- Arthromatic/Uromatic 2C4041Baxter International Inc. · System, irrigation, urological40 reports
- MEDLINE DYND19122Medline Industries, Inc. · System, irrigation, urological7 reports
- MEDLINE DYND19120Medline Industries, Inc. · System, irrigation, urological3 reports
- Irrigation Set 313003B. Braun Medical Inc. · System, irrigation, urological2 reports
- Medline DYND19140Medline Industries, Inc. · System, irrigation, urological1 report
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
- 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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