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Medline Industries, Inc. DYKE1649ARecalls & 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 10193489375152), received between Nov 2, 2021 and Nov 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

Most reported problems

Device problems

  • Leak/Splash2

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.

  • MalfunctionNov 2, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE VALVES WERE LEAKING AND THE CLINICIAN COULD NOT INSUFFLATE USING CO2 WHEN DOING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12737499 ↗
  • MalfunctionNov 2, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE VALVES WERE LEAKING AND THE CLINICIAN COULD NOT INSUFFLATE USING CO2 WHEN DOING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12737243 ↗

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Sources and updates

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