Medline Industries, Inc. DYNJRA0345GRecalls & reported problems
Medline Industries, Inc. · PROCEDURE TRAY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327517083), received between Mar 30, 2026 and Sep 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
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
- Improper Flow or Infusion1
- Leak/Splash1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564756 ↗MalfunctionMay 17, 2026Leak/Splash
IT WAS REPORTED THAT, DURING A PROCEDURE, AS THE PHYSICIAN WAS DEPRESSING THE SYRINGE PLUNGER (WITH THE SYRINGE ATTACHED TO A NEEDLE INSERTED IN THE PATIENT'S BACK), FLUID WAS OBSERVED LEAKING FROM THE BASE OF THE SYRINGE AT THE CONNECTION POINT WITH THE NEEDLE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196819 ↗MalfunctionMar 30, 2026Improper Flow or Infusion
IT WAS REPORTED THAT ON (B)(6) 2026, "10ML SYRINGE-PRESSURE WENT UP THE BARREL INSTEAD OF OUT THE SYRINGE". CUSTOMER CONTACT STATED, "NO IMPACT TO PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729688 ↗
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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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