MEDLINE MDT2168284Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20080196282736), received between Sep 23, 2020 and Sep 30, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Particulates” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Particulates

  It was reported that Clinical Staff were using towels in the OR and surgeons notice that the patients were covered in lint from the towels. these are supposed to be the low lint towels, and having this happen creates a possible contaminatino issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947370 ↗
• MalfunctionSep 25, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902979 ↗
• MalfunctionSep 25, 2026Particulates

  It was reported that "The towels are linting with wire use in the IR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898795 ↗
• MalfunctionSep 23, 2026Particulates

  It was reported that black fuzzies/ lint on OR towels.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868721 ↗
• MalfunctionSep 23, 2026Contamination

  It was reported that "Upon opening the product had loose lint on the towels. These are supposed to be lintless so they could not be used."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867296 ↗
• MalfunctionSep 21, 2026Particulates

  It was reported that "OR Towel linting issue. The towel was used to dry my skin after a wet surgical scrub."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846165 ↗
• MalfunctionSep 16, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796445 ↗
• MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  It was reported that "there appears to be lint on towel."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793505 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786802 ↗
• MalfunctionSep 14, 2026Particulates; Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759752 ↗
• MalfunctionMay 29, 2026Material Fragmentation

  IT WAS REPORTED THAT THE TOWELS LEAVE BLUE LINT ON HANDS AFTER DRYING, AS WELL AS ON INSTRUMENTS. ALSO NOTED THAT PARTICLES ARE IN THE AIR DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 25340666 ↗
• InjuryMay 1, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2023 "A BLUE OPERATING ROOM TOWEL WAS GRABBED DURING AN OPEN GENERAL SURGERY PROCEDURE TO DRY OFF THE LIGHT COVER AND DEBRIS WAS FALLING FROM THE LIGHT ONTO THE SURGICAL FIELD".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16843613 ↗
• MalfunctionApr 16, 2021Device Contamination with Chemical or Other Material

  IT WAS REPORTED, "THE OPERATING ROOM (OR) TOWELS HAVING LINT/FIBERS & IT SPREAD ALL OVER TO THE SURGICAL GLOVES, INSTRUMENTS, DRAPES & POTENTIALLY ON THE PATIENT. THIS IS HAPPENING IN THE MIDDLE OF THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681357 ↗
• MalfunctionSep 23, 2020Material Fragmentation

  IT WAS REPORTED, DISPOSABLE OR TOWELS WERE TRANSFERRING LINT TO EYE MUSCLE AND CLINGING TO SUTURE WHICH NEEDED TO BE CLEANED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10578076 ↗