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Medline Industries, Inc. DYNJ66107Recalls & reported problems

Medline Industries, Inc. · GYNE ROBOTIC PACK-LF · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489320121), received between Dec 14, 2020 and Dec 14, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn2

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.

  • InjuryDec 14, 2020Material Split, Cut or Torn

    IT WAS REPORTED THAT THE X-RAY DETECTABLE (XRD) GAUZE TORE DURING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11003016 ↗
  • InjuryDec 14, 2020Material Split, Cut or Torn

    IT WAS REPORTED THAT THE X-RAY DETECTABLE (XRD) GAUZE TORE DURING A PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11002699 ↗

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Sources and updates

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