NA MST-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640141626146), received between Feb 16, 2023 and Jun 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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.

• MalfunctionJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN EMPLOYEE WAS LOADING THE WASHER AND BUMPED THE RIGHT UPRIGHT TRIM PANEL WITH THE LOADING CART, CAUSING THE PANEL TO FALL OFF ITS MOUNTINGS AND HIT HER ON THE HEAD. SHE WAS NOT INJURED AND DID NOT REQUIRE MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320229 ↗
• MalfunctionAug 20, 2024Mechanical Problem; Improper or Incorrect Procedure or Method; Mechanical Problem; Improper or Incorrect Procedure or Method

  THE STERILIZER, EQUIPPED WITH A GROUND-LOADING SYSTEM AND DESIGNED FOR AUTOMATIC LOADING AND UNLOADING, EXPERIENCED A MALFUNCTION DURING THE UNLOADING PROCESS. DURING THE INCIDENT, THE UNLOADING FUNCTION EXECUTED ONLY PARTIALLY, LEAVING THE SECOND CART INSIDE THE UNIT. THE SPD TECHNICIAN ATTEMPTED TO MANUALLY REMOVE THE SECOND CART USING A METAL ROD. IN THE PROCESS SHE BACKED UP INTO A HOT RACK THAT HAD BEEN LEFT THERE TO COOL DOWN, RESULTING IN BURNS WITH BLISTERING AND PEELING ON HER ARM. MEDICAL CARE WAS PROVIDED BY EMPLOYEE HEALTH SERVICES AND THE TECHNICIAN WAS ABLE TO RETURN TO WORK.

  Patient problems: Burn(s)

  MAUDE report 20004371 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE RIGHT-HAND LOAD-SIDE VERTICAL DOOR FRAME PANEL OF THE STERILIZER FELL OFF, ALMOST HITTING AN EMPLOYEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866908 ↗
• MalfunctionApr 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN EMPLOYEE WAS REMOVING A CASE CART FROM THE WASHER. THE CART BUMPED THE SIDE PANEL OF THE DOOR FRAME, CAUSING IT TO FALL OFF AND HIT THE EMPLOYEE IN THE HEAD. THE EMPLOYEE WAS CHECKED BY IN-HOUSE CARE AND ABLE TO RETURN TO NORMAL WORKING SCHEDULE ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701043 ↗
• MalfunctionFeb 16, 2023Problem with Software Installation; Problem with Software Installation

  DURING INSTALLATION OF A STERILIZER, A GRAVITY CYCLE WAS RELABELED AS PREVACUUM AND THE PROGRAM PARAMETERS WERE CHANGED ACCORDINGLY, BUT THE CHANGED PARAMETERS WERE NOT SAVED. AFTER SHUTDOWN OF THE SYSTEM THE PARAMETERS REVERTED TO THE ORIGINAL GRAVITY CYCLE PARAMETERS WHILE MAINTAINING THE PREVACUUM LABEL. INADVERTENTLY THE INCORRECTLY LABELED CYCLE WAS RUN THREE TIMES OVER THE FOLLOWING TWO MONTHS BEFORE BEING DETECTED AND CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388197 ↗