Medline Industries, Inc. CDS985340ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942661060), received between May 21, 2018 and May 21, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2018Metal Shedding Debris

  IT WAS REPORTED THAT THE OPERATING ROOM TOWEL WAS SHEDDING LINT DURING AN UNIDENTIFIED VASCULAR PROCEDURE. AFTER AN UNIDENTIFIED PERIOD OF TIME, THE PATIENT REPORTEDLY RETURNED WITH A SURGICAL SITE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7529679 ↗
• MalfunctionMay 21, 2018Material Frayed

  IT WAS REPORTED THAT THE OPERATING ROOM (OR) TOWEL WAS SHEDDING LINT DURING AN UNIDENTIFIED VASCULAR PROCEDURE. AFTER AN UNIDENTIFIED PERIOD OF TIME, THE PATIENT REPORTEDLY RETURNED WITH A SURGICAL SITE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7529627 ↗
• MalfunctionMay 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OR TOWEL WAS SHEDDING LINT DURING AN UNIDENTIFIED VASCULAR PROCEDURE. AFTER AN UNIDENTIFIED PERIOD OF TIME, THE PATIENT REPORTEDLY RETURNED WITH A SURGICAL SITE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7529504 ↗