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MEDLINE NON21448Recalls & reported problems

Medline Industries, Inc. · GAUZE,SPONGE,4"X4",8PLY,STRL,LF,2/PK · Class 1

Data updated Oct 13, 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 20080196690876), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Delivered as Unsterile Product1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionAug 29, 2018Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

    SMALL BROWN SPOT NOTED ON STERILE GAUZE WHEN IT WAS REMOVED FROM THE PACKAGING. NO DISCOLORATION SEEN ON THE PACKAGING.

    Patient problems: No Information

    MAUDE report 7832213 ↗

Other Gauze / sponge,nonresorbable for external use devices

All Gauze / sponge,nonresorbable for external use devices →

Sources and updates

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