MEDLINE MDT2168286Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20080196282743), received between May 24, 2018 and Sep 24, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Flaked” (4 reports).

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Disintegration

  It was reported that the surgeon and staff displayed their concern during an open abdomen case. They were noticing increased linting from the towels remaining on the intestines during the procedure requiring added time to remove as much as possible.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885415 ↗
• MalfunctionSep 16, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793430 ↗
• MalfunctionSep 16, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790774 ↗
• MalfunctionJul 27, 2026Material Disintegration

  It was reported that the OR Towels have lint that has been coming off and finding it in their heparinized saline bowls and after they wipe their wires down. There is a concern that this can potentially cause harm to a patient while doing angio type procedures.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038090 ↗
• MalfunctionJun 3, 2026Flaked

  IT WAS REPORTED THE MDT2168286 CONTINUE TO BE OF POOR QUALITY LEAVING THREAD FRAGMENTS AND BLUE FUZZ IN STERILE BASINS AFTER BEING PLACED IN STERILE FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385575 ↗
• MalfunctionJun 3, 2026Flaked

  IT WAS REPORTED THE MDT2168286 CONTINUE TO BE OF POOR QUALITY LEAVING THREAD FRAGMENTS AND BLUE FUZZ IN STERILE BASINS AFTER BEING PLACED IN STERILE FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385570 ↗
• MalfunctionJun 3, 2026Flaked

  IT WAS REPORTED THE MDT2168286 CONTINUE TO BE OF POOR QUALITY LEAVING THREAD FRAGMENTS AND BLUE FUZZ IN STERILE BASINS AFTER BEING PLACED IN STERILE FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385568 ↗
• MalfunctionMay 5, 2026Flaked

  CUSTOMER STATES, "THE STAFF PLACED A PIECE OF WHAT APPEARS TO BE PACKING TAPE ON THE TOWEL THAT THEY SAID THEY USED TO DEMONSTRATE THE LINT THAT WAS COMING OFF THE TOWELS. THE PROCEDURAL OPERATIONS MANAGER INDICATED VERBALLY THAT HE THINKS IT IS MOST LIKELY JUST THE SMALL FIBERS WITHIN THE TOWEL, BUT THE DOCTOR IS APPARENTLY SEEING THIS "LINT" WHEN SHE IS TRYING TO VIEW AN OBJECT THAT IS LAID DOWN ON TOP OF THE TOWEL UNDER THE MICROSCOPE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089749 ↗
• MalfunctionSep 8, 2022Device Contamination with Chemical or Other Material

  OPENED PRODUCT CASE TO RESTOCK. FOUND AN UNKNOWN LIQUID WITHIN THE PLASTIC LINER OF THE CASE WHERE THE PRODUCT IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378246 ↗
• InjuryMay 24, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BLUE OR TOWELS WERE "LINTING IN CHUNKS AND MAY HAVE CAUSED AN INFECTION."

  Patient problems: Post Operative Wound Infection

  MAUDE report 7542673 ↗
• InjuryMay 24, 2018Contamination; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BLUE OPERATING ROOM TOWELS WERE "LINTING IN CHUNKS AND MAY HAVE CAUSED AN INFECTION."

  Patient problems: Post Operative Wound Infection

  MAUDE report 7542472 ↗