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Medline DYNJP4104HDARecalls & reported problems

Medline Industries, Inc. · DRAPE,FEM ANGIO,2 WIN,STERILE · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277370784), received between Sep 1, 2026 and Sep 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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: 3 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Material Integrity Problem1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50652829 ↗
  • MalfunctionSep 2, 2026Material Integrity Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50563906 ↗
  • MalfunctionSep 1, 2026Fluid/Blood Leak

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 50544729 ↗

Other Drape, surgical devices

All Drape, surgical devices →

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