Medline-Microtek Surgical Slush - Hush-Slush Drape (REF ESD340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00748426140329), received between Nov 13, 2025 and Jun 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 18, 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.

• MalfunctionJun 18, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER FOUND HOLES IN A STERILE DRAPE DURING USE. TWO UNITS ESD340, WERE AFFECTED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555051 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT STERILE SLUSHWARMER DRAPES (SKU ESD340) HAD "MICROHOLES" AND SLICING DURING USE WHEN WATER/ICE ACCUMULATED BENEATH THE DRAPE. TWO UNITS FROM LOTS 3195LA1100 AND 5375LA0100 WERE REPORTED. THE CUSTOMER STATED ONLY GLOVED HANDS WERE USED AND NO SHARPS OR INSTRUMENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283571 ↗
• MalfunctionDec 1, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE OR STAFF NOTICED THE SLUSH DRAPE ESD340 HAD A HOLE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680721 ↗
• MalfunctionNov 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPROTED THAT AT THE END OF THE SURGICAL PROCEDURE, FLUID WAS OBSERVED POOLING ON THE WARMER SIDE OF THE SLUSH DRAPE. UPON INSPECTION, A SECTION OF THE DRAPE APPEARED MELTED OR THINNED, WHICH WAS NOT NOTICED DURING SETUP. THE LEAK ALLOWED SALINE AND SURGICAL CONTENTS TO COLLECT IN THE WARMER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547827 ↗