MEDLINE PRM25865Recalls & reported problems
Medline Industries, Inc. · BANDAGE,GAUZE,4.5"X4.1YD,STERILE,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 10080196694082), received between Nov 1, 2023 and Nov 1, 2023 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
"BROWN CONTAMINANT" WAS NOTED ON ROLL OF GAUZE.
Patient problems: Insufficient Information
MAUDE report 18048426 ↗
Other Gauze / sponge,nonresorbable for external use devices
- CVS Health 894111Woonsocket Prescription Center, Incorporated · Gauze / Sponge,Nonresorbable For External Use1 recall0 reports
- Curad CUR47147RBMedline Industries, Inc. · Gauze / sponge,nonresorbable for external use9 reports
- MEDLINE INDUSTRIES, INC. NON25212Medline Industries, Inc. · Gauze / sponge,nonresorbable for external use5 reports
- MEDLINE INDUSTRIES, INC. PRM21408CMedline Industries, Inc. · Gauze / sponge,nonresorbable for external use4 reports
- Curad CUR47397RBMedline Industries, Inc. · Gauze / sponge,nonresorbable for external use4 reports
- CURAD NON25700Medline Industries, Inc. · Gauze / sponge,nonresorbable for external use3 reports
- Medline NON25865Medline Industries, Inc. · Gauze / sponge,nonresorbable for external use2 reports
- MEDLINE NON25441Medline Industries, Inc. · Gauze / sponge,nonresorbable for external use2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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