Medline DYND70280Recalls & reported problems
Medline Industries, Inc. · SYRINGE,EAR/ULCER, 2 OZ, STERILE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196035038), received between Mar 21, 2024 and Sep 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Problem3
- Break1
- Contamination /Decontamination Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Contamination /Decontamination Problem
It was reported that ONE THAT IS SEALED APPEARS TO HAVE LITTLE BUGS ON THE INSIDE OF THE SEALED PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945670 ↗MalfunctionSep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PLASTIC INFANT BULB SUCTION BROKEN WHEN PACKAGE OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088970 ↗MalfunctionAug 25, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, PRIOR TO USE, THE DEVICE WAS "BROKEN WHEN PACKAGE OPENED." THE CUSTOMER REPORTED THAT THERE WAS "NO HARM TO PATIENT OR CLINICAL STAFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882496 ↗MalfunctionJun 13, 2025Suction Problem; Suction Problem
MINIMAL SUCTION FROM THE BULB SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203711 ↗MalfunctionMar 21, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE EAR ULCER SYRINGE WAS "NOT SUCTIONING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954356 ↗MalfunctionMar 21, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE EAR ULCER SYRINGE HAD "POOR RECOIL" AND NO SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954331 ↗
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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