AMSCO AMSCO 400 Steam Sterilizer (REF SR0201110311)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00724995209445), received between Aug 16, 2023 and Jul 13, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K111223, K212424); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25802367 ↗
• MalfunctionMay 15, 2026Leak/Splash

  THE USER FACILITY REPORTED WATER AND STEAM LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188546 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A STEAM LEAK FROM THEIR SMALL AMSCO 400 STERILIZER. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074263 ↗
• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037654 ↗
• MalfunctionMay 22, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A WATER LEAK FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069569 ↗
• MalfunctionMar 26, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700606 ↗
• MalfunctionOct 14, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A WATER LEAK FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441178 ↗
• MalfunctionJul 3, 2024Temperature Problem; Temperature Problem

  THE USER FACILITY REPORTED THEIR AMSCO 400 STERILIZER MADE A "POPPING NOISE" AND HAD "SMOKE" COMING FROM THE BOTTOM OF THE UNIT. THE UNIT WAS REMOVED FROM SERVICE TO AWAIT ONSITE INSPECTION. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672099 ↗
• MalfunctionAug 16, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT STEAM LEAKED FROM THE VIEW PORT OF THEIR AMSCO 400 STERILIZER WHILE AN EMPLOYEE WAS PRESENT. THE STEAM LEAK CAUSED PRESSURE TO RELEASE FROM THE STERILIZER'S GENERATOR CREATING A SOUND WAVE THAT AFFECTED THE EMPLOYEE'S HEARING AIDS. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED.

  Patient problems: Headache

  MAUDE report 17556746 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111223, K212424. One submission often covers many models, so check the product and lot details in each record.

• Z-0210-2016 · Sep 3, 2015 · Terminated
  AMSCO 400 and AMSCO C Small Steam Sterilizers
• Z-1561-2015 · Feb 19, 2015 · Terminated
  AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat
• Z-0915-2013 · Feb 12, 2013 · Terminated
  AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.