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Medline DYNJWE1305Recalls & reported problems

Medline Industries, Inc. · RESERVOIR,SUCTION,100CC,SILICONE · Class 1

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196966219), received between Sep 2, 2026 and Sep 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 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: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 8 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component5
  • Decrease in Suction3
  • Suction Problem3
  • Deflation Problem1
  • Fluid/Blood Leak1
  • Suction Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2026Suction Problem; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50926388 ↗
  • MalfunctionSep 25, 2026Fluid/Blood Leak

    It was reported that "We have experienced issues with drain bulbs not holding suction" and "The drain system is not holding a seal at the junction just above the body of the bulb."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50899109 ↗
  • MalfunctionSep 24, 2026Decrease in Suction; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50882878 ↗
  • MalfunctionSep 17, 2026Suction Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810261 ↗
  • MalfunctionSep 12, 2026Decrease in Suction; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50746657 ↗
  • MalfunctionSep 10, 2026Suction Problem; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50722669 ↗
  • MalfunctionSep 8, 2026Deflation Problem; Suction Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50673012 ↗
  • MalfunctionSep 2, 2026Decrease in Suction; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50569088 ↗

Other APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices

All APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED devices →

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