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Medline Industries, Inc. DYNJ46051ARecalls & reported problems

Medline Industries, Inc. · GEN LAPAROSCOPY PACK · 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 10889942185528), received between Mar 2, 2020 and Mar 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 4, 2020Material Fragmentation

    IT WAS REPORTED THAT THE GAUZE COMPONENT WAS IDENTIFIED TO BE SHREDDING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9789757 ↗
  • MalfunctionMar 2, 2020Material Fragmentation

    IT WAS REPORTED THAT THE GAUZE COMPONENT WAS IDENTIFIED TO BE SHREDDING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9775652 ↗

Other laparoscopy kit devices

All laparoscopy kit devices →

Sources and updates

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