AMSCO AMSCO 400 Steam Sterilizer (REF SR2221211011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00724995210137), received between Feb 11, 2022 and Aug 7, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE BOTTOM PANEL TO THEIR AMSCO 400 STERILIZER DETACHED AND CONTACTED THE EMPLOYEE'S FOOT (BRUISE). THE EMPLOYEE WENT TO THE EMERGENCY ROOM. THE USER FACILITY DID NOT DISCLOSE FURTHER MEDICAL INFORMATION.

  Patient problems: Bruise/Contusion

  MAUDE report 22743415 ↗
• MalfunctionMar 1, 2025Failure to Align; Failure to Align

  THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR AMSCO 400 STERILIZER THEIR ELBOW CONTACTED THE DOOR AND OBTAINED A BURN. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 21499640 ↗
• MalfunctionNov 22, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT #(B)(4) THAT THE PANEL FOR THEIR AMSCO 400 STERILIZER DOOR HINGE COVER IS GETTING CAUGHT ON THE DOOR CAUSING THE DOOR TO BECOME DAMAGED AND DIFFICULT TO OPEN AND CLOSE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843787 ↗
• MalfunctionAug 19, 2022Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH #(B)(4) THAT THE DOOR LOCKING MECHANISM ON THEIR AMSCO 400 STERILIZER WOULD NOT LOCK OR UNLOCK CAUSING LOADS TO BE STUCK INSIDE OR CAUSE LOADS TO NOT BE RUN. NO PROCEDURE DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257844 ↗
• MalfunctionFeb 11, 2022Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT #(B)(4) THAT THEIR AMSCO 400 STERILIZER DOOR LOCK/UNLOCKMECHANISM WAS NOT WORKING PROPERLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514781 ↗

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.