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
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
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2414RMedline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP8201UGMedline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2412TMedline Industries, Inc. · Drape, surgical2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.