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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All SYRINGE, IRRIGATING (NON DENTAL) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.