MEDLINE DYND20323Recalls & reported problems
Medline Industries, Inc. · SYRINGE,TOOMEY,IRRIGATION,70CC,STERILE · Class 1
Data updated Oct 18, 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 10884389106303), received between Mar 21, 2024 and Aug 13, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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
- Leak/Splash2
- Contamination1
- Detachment of Device or Device Component1
- Failure to Seal1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE SYRINGE WAS "DEFECTIVE, NOT WORKING PROPERLY".
Patient problems: Insufficient Information
MAUDE report 22794395 ↗MalfunctionMay 2, 2025Contamination; Contamination
IT WAS REPORTED THAT ON 03/26/2025 THAT THERE WAS FOREIGN PARTICULATE IDENTIFIED "WITHIN THE PACKAGING" WHILE "PUTTING ON THE SHELF".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951161 ↗MalfunctionJan 3, 2025Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY, "DUE TO THE DETACHABLE NATURE OF THE TIP, AS WELL AS THE POOR SEAL BETWEEN THE PISTON AND SYRINGE, IT IS IMPOSSIBLE TO GENERATE ENOUGH NEGATIVE PRESSURE TO ADEQUATELY IRRIGATE. IN ADDITION, DUE TO THE DETACHABLE TIP, THERE HAVE BEEN MULTIPLE INSTANCES WHERE THAT TIP BECAME DETACHED DURING IRRIGATION, CAUSING SPILLAGE OR DANGEROUS SPRAY OF BLOODY URINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067723 ↗MalfunctionMar 21, 2024Leak/Splash; Failure to Seal; Leak/Splash; Failure to Seal
IT WAS REPORTED THAT MEDICATION LEAKED AROUND THE PLUNGER OF THE IRRIGATION SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954382 ↗MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLUNGER OF THE IRRIGATION SYRINGE "COMES OFF" DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954380 ↗
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
- Rapid Refill M00566000Boston Scientific Corporation · SYRINGE, IRRIGATING (NON DENTAL)1 recall0 reports
- NICO Fluid System NN-8015Nico 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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