Medline-Microtek Fluid Warming - Warmer Drape (REF ORS-100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00748426143603), received between Feb 5, 2026 and Jul 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791296 ↗
• MalfunctionJun 23, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER OBSERVED TINY PIN-SIZE HOLES IN A STERILE WARMING DRAPE (ORS-100) DURING USE. ONE UNIT WAS AFFECTED. THE LOT NUMBER COULD NOT BE CONFIRMED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602397 ↗
• MalfunctionApr 11, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE WARMER DRAPE MELTED A HOLE WHILE IN USE CONTAMINATING THE CONTENTS OF THE CONTAINER IT WAS HOLDING, (NS, AS REPORTED BY THE USER). NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847950 ↗
• MalfunctionFeb 12, 2026Material Puncture/Hole

  CUSTOMER REPORTED THAT THE ITEM HAD MICROSCOPIC HOLES ON THE BOTTOM. ONE UNIT (ORS-100 DRAPE WARMER) FROM LOT 3265LA0400 WAS REPORTED AS AFFECTED. NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328096 ↗
• MalfunctionFeb 5, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A STERILE FLUID WARMER DRAPE (SKU ORS-100) WAS FOUND WITH A HOLE, DURING SURGERY. ONE UNIT FROM LOT 4295LA0900 WAS AFFECTED. NO IMAGES OR SAMPLES WERE PROVIDED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273564 ↗