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Medline Industries, Inc. DYNJ0977627FRecalls & reported problems

Medline Industries, Inc. · LAPAROTOMY UNIVERSAL PACK-LF · 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 10889942551545), received between Sep 27, 2019 and Oct 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1
  • Fire1
  • Peeled/Delaminated1

Patient problems

  • Foreign Body In Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 16, 2019Peeled/Delaminated; Contamination /Decontamination Problem

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A WHITE LABEL FROM A TOWEL FELL OFF INTRAOPERATIVELY INTO TA PATIENT'S ABDOMINAL CAVITY.

    Patient problems: Foreign Body In Patient

    MAUDE report 9197705 ↗
  • MalfunctionSep 27, 2019Fire

    IT WAS REPORTED THAT THE TIP OF THE COVIDIEN CAUTERY DEVICE CAUGHT ON FIRE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9130567 ↗

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Sources and updates

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