AMSCO AMSCO 400 Steam Sterilizer (REF SR0101110111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995209230), received between Jun 30, 2022 and Sep 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782781 ↗
• MalfunctionJun 30, 2022Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN OVER PRESSURE ALARM OCCURRED ON THEIR AMSCO 400 STERILIZER. FOLLOWING THE ALARM, THE USER FACILITY SHUT OFF THE ELECTRICAL UTILITIES FOR THE STERILIZER BUT INADVERTENTLY LEFT THE SEPARATE ELECTRICAL UTILITIES TO THE STERILIZER'S STEAM GENERATOR POWERED ON, SUBSEQUENTLY CAUSING THE UNIT TO OVERHEAT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14878872 ↗

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.