AMSCO AMSCO 400 Steam Sterilizer (REF SR0101110311)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00724995209254), received between Sep 22, 2022 and Nov 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A STEAM "BURN" TO THE BACK OF THEIR HAND WHILE OPENING THEIR AMSCO 400 STERILIZER DOOR AND REACHING FOR THE CYCLE PRINTOUT TAPE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 23544742 ↗
• MalfunctionSep 11, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A STEAM LEAK AND "LOUD NOISE" FROM THEIR AMSCO 400 STERILIZER. AS A RESULT, AN EMPLOYEE EXPERIENCED RINGING IN THEIR EARS. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Ear Pain

  MAUDE report 23030694 ↗
• MalfunctionMay 29, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT AN EMPLOYEE SLIPPED AND FELL ON WATER LEAKING FROM THEIR AMSCO 400 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Fall

  MAUDE report 22108581 ↗
• MalfunctionOct 4, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT FOLLOWING AN ABORTED CYCLE, AN EMPLOYEE SUFFERED A BURN TO THEIR FACE AND A BLISTER ON THEIR LIP WHEN THEIR FACE CONTACTED STEAM AFTER OPENING THEIR AMSCO 400 STERILIZER DOOR. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND WAS GIVEN ICE.

  Patient problems: Burn(s)

  MAUDE report 20368943 ↗
• MalfunctionMay 15, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326009 ↗
• MalfunctionJan 3, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437925 ↗
• MalfunctionSep 22, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464189 ↗

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.