Medline-Microtek Fluid Warming - Warmer Drape (REF ORS-300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00748426143627), received between Mar 19, 2026 and Sep 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Puncture/Hole

  It was reported that a hole was suspected in a fluid warmer drape (ORS-300) during use in a surgical procedure. One unit was affected. The lot number was not provided. No patient injuries or complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899761 ↗
• MalfunctionJun 17, 2026Material Puncture/Hole

  DURING ROOM CLEAN-UP, A POOL OF FLUID WAS IDENTIFIED UNDER A WARMER DRAPE. THE PRODUCT INVOLVED WAS ORS-300. NO PATIENT INJURY OR EQUIPMENT DAMAGE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538061 ↗
• MalfunctionApr 25, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING A ROBOTIC MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2026, THE USER FACILITY REPORTED THAT A DISPOSABLE SURGICAL WARMER DRAPE WAS LATER FOUND TO HAVE A HOLE. THE HOLE WAS IDENTIFIED DURING POST-OPERATIVE CLEAN-UP AFTER THE PATIENT HAD ALREADY LEFT THE OPERATING ROOM. THE WARMER DRAPE IS USED TO MAINTAIN STERILE FLUID IN THE SURGICAL FIELD; THE DRAPE WAS FOUND COMPROMISED WITH A HOLE. THE USER FACILITY REPORTED THAT NO SHARP INSTRUMENTS WERE PLACED IN THE DRAPE DURING THE PROCEDURE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993098 ↗
• MalfunctionMar 19, 2026Material Puncture/Hole

  ON 02/17/2026, (B)(6) HOSPITAL REPORTED RECEIVING TWO (2) STERILE ORS-300 WARMER DRAPES WITH HOLES. NO PHOTOS, VIDEOS, OR SAMPLES WERE PROVIDED FOR EVALUATION. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645987 ↗