AMSCO AMSCO 400 Steam Sterilizer (REF SR0201110111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995209421), received between Mar 8, 2023 and Sep 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Leak/Splash

  The user facility reported that their AMSCO 400 Sterilizer was leaking water and emitting a ¿burning odor¿. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882026 ↗
• MalfunctionFeb 12, 2026Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326067 ↗
• MalfunctionJan 9, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT AN EMPLOYEE HAD REDNESS ON THEIR FACE FROM STEAM AFTER OPENING THE DOOR OF THEIR AMSCO 400 STERILIZER. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 24021057 ↗
• MalfunctionDec 4, 2025Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT SMOKE EMITTED FROM THE BACK OF THEIR AMSCO 400 STERILIZER DURING A CYCLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717384 ↗
• MalfunctionMar 8, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS PRODUCING WET INSTRUMENT PACKS FOLLOWING COMPLETED CYCLES. THIS CAUSED PATIENT PROCEDURES TO BE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506348 ↗
• MalfunctionMar 8, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS PRODUCING WET INSTRUMENT PACKS FOLLOWING COMPLETED CYCLES. THIS CAUSED PATIENT PROCEDURES TO BE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506276 ↗

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.