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MEDLINE NON25430Recalls & reported problems

Medline Industries, Inc. · GAUZE,SPONGE,XRAY,4"X4",16PLY,NS,LF · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20080196752857), received between Mar 6, 2020 and Mar 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2020Break

    IT WAS REPORTED THAT X-RAY DETECTABLE GAUZE IS COMING APART DURING USE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9799677 ↗

Other Gauze / sponge,nonresorbable for external use devices

All Gauze / sponge,nonresorbable for external use devices →

Sources and updates

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