MEDLINE INDUSTRIES, INC. PRM21408CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196694013), received between Sep 16, 2019 and Sep 16, 2026 — classified as 4 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790267 ↗
• MalfunctionSep 14, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758708 ↗
• MalfunctionNov 25, 2020Material Fragmentation

  IT WAS REPORTED FRAGMENTS OF NONSTERILE 100% COTTON WOVEN GAUZE SPONGE HAD COME OFF ON TO A PATIENT'S SURGICAL SITE DURING A MOHS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901279 ↗
• MalfunctionSep 16, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT SMALL PIECES OF LINT FROM GAUZE SPONGES REACHED PATIENTS' WOUNDS, WHICH REQUIRED IRRIGATION AND LIGHT DEBRIDEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071694 ↗