AMSCO AMSCO 400 Steam Sterilizer (REF SR0201210011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995209506), received between Aug 19, 2022 and Aug 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT TWO BOTTOM PANELS FROM THEIR AMSCO 400 STERILIZER FELL OFF AND CONTACTED AN EMPLOYEE'S FOOT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293063 ↗
• MalfunctionAug 19, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5110794 THAT THEIR AMSCO 400 STERILIZER'S SHROUDING KEEPS GETTING OUT OF ALIGNMENT AND THE STAFF SIMPLY PUSHES THE METAL SHROUDING TO THE SIDE AND CONTINUES WITH THEIR WORK. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259550 ↗

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.