Medline ENT6006MRecalls & reported problems
Medline Industries, Inc. · SYRINGE,PISTON,IRRIGATION,60ML,STERILE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888277317581), received between Mar 15, 2024 and Apr 2, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Connection Problem1
- Leak/Splash1
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE SYRINGE "ENDED UP LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020932 ↗MalfunctionMar 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE FELT "FLIMSY.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18950359 ↗MalfunctionMar 15, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE SUCTION FROM THE PISTON IRRIGATION SYRINGE WAS "HIT OR MISS.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18918027 ↗MalfunctionMar 15, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE LEAKED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18918026 ↗MalfunctionMar 15, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE TIP OF THE PISTON IRRIGATION SYRINGE IS DETACHING FROM A TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18917998 ↗
Other SYRINGE, IRRIGATING (NON DENTAL) devices
- Irrigation Syringe 0935280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)83 reports
- N/A 309620Becton, Dickinson And Company · SYRINGE, IRRIGATING (NON DENTAL)73 reports
- Irrigation Syringe 0035280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)58 reports
- MEDLINE DYND20125Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)1 recall3 reports
- NICO Fluid System NN-8015Nico Corporation · Syringe, Irrigating (Non Dental)1 recall0 reports
- Rapid Refill M00566000Boston Scientific Corporation · SYRINGE, IRRIGATING (NON DENTAL)1 recall0 reports
- MEDLINE DYND20302Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
- Piston Irrigation Tray 750307C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 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
- 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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