Medline Industries, Inc. DYKE1848ARecalls & reported problems
Medline Industries, Inc. · ENDO KIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327223533), received between Sep 9, 2026 and Sep 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fitting 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fitting Problem2
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fluid/Blood Leak; Fitting Problem
It was reported that ¿Buttons leaking and not fitting properly. They end up leaking on the set up tray and they squirt/spray excess fluid out when they are utilizing the scope.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752867 ↗MalfunctionSep 9, 2026Fluid/Blood Leak; Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699196 ↗
Other Endoscope introducer kit devices
- Medline Industries, Inc. DYNJ44673GMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ66447Medline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ58648JMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- ACS BUCY78EAmerican Contract Systems, Inc. · Endoscope introducer kit2 recalls0 reports
- ACS LVCY20AAmerican Contract Systems, Inc. · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH PGVMDVB26Cardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH SOT51CPKOACardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH PGOCRDNHDCardinal Health 200, LLC · Endoscope introducer kit1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page