AMSCO AMSCO 400 Steam Sterilizer (REF SR2321211011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995210564), received between Jul 20, 2023 and May 16, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K111223, K112055, K112403, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Failure to Align; Failure to Align

  THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR FACE WHILE RETRIEVING A RACK "STUCK" IN THEIR AMSCO 400 STEAM STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 22036157 ↗
• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542149 ↗
• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT AN EMPLOYEE'S ARM WAS CONTACTED BY STEAM WHEN THE CHAMBER DOOR WAS OPENED TO THEIR AMSCO 400 STERILIZER. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT (OINTMENT).

  Patient problems: Pain

  MAUDE report 17362624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111223, K112055, K112403, K212424. One submission often covers many models, so check the product and lot details in each record.

• Z-0586-2020 · Oct 22, 2019 · Terminated
  Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
• 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.