MEDLINE MDT2168204Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20080196834058), received between Nov 30, 2017 and Sep 25, 2026 — classified as 1 injury, 17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping

  It was reported that "We have had a couple packs of sterile towels have pieces of lint inside them."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899955 ↗
• MalfunctionSep 21, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846510 ↗
• MalfunctionSep 21, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840835 ↗
• MalfunctionSep 17, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811135 ↗
• MalfunctionSep 17, 2026Particulates

  It was reported that small towel fibers or lint appear to be sticking to surgical gloves during procedures. The concern is that these fibers may be entering the surgical site.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803982 ↗
• MalfunctionSep 16, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787553 ↗
• MalfunctionSep 15, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779956 ↗
• MalfunctionSep 15, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779875 ↗
• MalfunctionSep 14, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762951 ↗
• MalfunctionSep 14, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752712 ↗
• MalfunctionSep 13, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747057 ↗
• MalfunctionSep 8, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676387 ↗
• MalfunctionJun 5, 2026Material Frayed

  IT WAS REPORTED THAT THE OR TOWEL WAS LINTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415355 ↗
• InjuryAug 1, 2023Material Integrity Problem; Material Integrity Problem

  PER THE FACILITY "EXCESSIVE LINT ON TOWELS GOT INTO PATIENT'S BLOODSTREAM DURING CATHETERIZATION PROCEDURE".

  Patient problems: Foreign Body In Patient

  MAUDE report 17434997 ↗
• MalfunctionMar 1, 2023Material Integrity Problem; Material Integrity Problem

  OR TOWEL LINTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464083 ↗
• MalfunctionFeb 9, 2021Contamination /Decontamination Problem

  IT WAS REPORTED THERE IS A CONCERN WITH THE STERILE DISPOSABLE BLUE OPERATING ROOM TOWELS LEAVING LINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300454 ↗
• MalfunctionAug 22, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT USE OF FORCEPS AND IRRIGATION WAS REQUIRED TO SUCCESSFULLY RETRIEVE THE PIECES OF BLUE FIBERS COMING FROM LINTING OR TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806241 ↗
• MalfunctionNov 30, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  A SMALL BUG WAS FOUND IN OPENED DISPOSABLE BLUE TOWEL ON STERILE FIELD. THE STERILE SET UP WAS BROKEN DOWN BEFORE ANYTHING WAS USED. THE BUG WAS PHOTOGRAPHED AND THE TOWEL/PACKAGING WAS SAVED. NO HARM CAME TO THE PATIENT. THE STERILE FIELD WAS RESET AND THE PROCEDURE WAS COMPLETED AS PLANNED. PER SITE REPORTER: THE MEDLINE REP WAS MADE AWARE AND WILL ALERT THEIR QUALITY DEPARTMENT. THE TOWEL WILL BE HANDED OVER TO THE MEDLINE REP FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070381 ↗