Medline DYND70277Recalls & reported problems
Medline Industries, Inc. · SYRINGE,EAR/ULCER, 3 OZ, STERILE · Class 1
- 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 10080196862542), received between Mar 21, 2024 and Sep 22, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Suction Problem2
- Contamination1
- Material Integrity Problem1
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.
MalfunctionSep 22, 2026Suction Problem; Material Integrity Problem
It was reported that "THE ITEM HAS LITTLE TO NO SUCTION AND THEY THEY ARE VERY HARD TO SQUEEZE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854264 ↗MalfunctionMar 10, 2026Contamination
CUSTOMER STATED THAT THE HAIR WAS WITHIN THE PACKAGING, OUTSIDE OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557415 ↗MalfunctionOct 2, 2024Suction Problem; Suction Problem
ACCORDING TO THE FACILITY, "OUR L&D STAFF REPORTED THAT ONE OF THEM HAS BAD SUCTION AND THEY HAD TO CHANGE IT DURING A RESUSCITATION DUE TO IT NOT SUCTIONING".
Patient problems: Insufficient Information
MAUDE report 20351346 ↗MalfunctionMar 21, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE EAR ULCER SYRINGE WAS "HARD TO SQUEEZE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954329 ↗MalfunctionMar 21, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE EAR ULCER SYRINGE "APPEARS TO BE MUCH THICKER AND IT'S DIFFICULT TO COMPRESS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954318 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.