AMSCO AMSCO 400 Steam Sterilizer (REF SR0201210311)Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The AMSCO 400 Series 20 Prevacuum Steam Sterilizer with 38-inch Single Door Recessed is designed for sterilization of materials used in healthcare facilities. · Class 2
All models of AMSCO (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00724995209537), received between Sep 17, 2021 and Sep 1, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (10 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash10
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551728 ↗MalfunctionJun 25, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A CYCLE THEIR AMSCO 400 STERILIZER LEAKED STEAM SUBSEQUENTLY CAUSING THE FACILITY'S FIRE ALARM TO GO OFF. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627071 ↗MalfunctionMay 14, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A CYCLE THEIR AMSCO 400 STERILIZER LEAKED STEAM SUBSEQUENTLY CAUSING THE FACILITY'S FIRE ALARM TO GO OFF. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173962 ↗MalfunctionApr 8, 2026Leak/Splash
THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS LEAKING WATER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815799 ↗MalfunctionFeb 17, 2026Leak/Splash
THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS LEAKING WATER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369667 ↗MalfunctionSep 25, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED A WATER LEAK ONTO THE FLOOR FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304721 ↗MalfunctionApr 19, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED A BURNING SMELL AND STEAM LEAK FROM THEIR AMSCO 400 STERILIZER. THERE WAS A PROCEDURE DELAY REPORTED AS A RESULT OF THE EVENT. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19144894 ↗MalfunctionDec 28, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY OR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409110 ↗MalfunctionJul 19, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED A WATER LEAK FROM THE GENERATOR OF THEIR AMSCO 400 STEAM STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17350729 ↗MalfunctionMay 19, 2022Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER AND STEAM WERE LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438506 ↗MalfunctionSep 17, 2021Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED WATER LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12490707 ↗
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 · TerminatedAMSCO 400 and AMSCO C Small Steam Sterilizers
- Z-1561-2015 · Feb 19, 2015 · TerminatedAMSCO 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 · TerminatedAMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Other Sterilizer, steam devices
- NA P2131-2Fort Defiance Industries, LLC · Sterilizer, Steam1 recall0 reports
- STATCLAVE G4 Chamber Autoclave G4-621103Scican Ltd · Sterilizer, Steam1 recall0 reports
- STATCLAVE G4 Chamber Autoclave G4-622303Scican Ltd · Sterilizer, Steam1 recall0 reports
- NA AX083020003Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam23 reports
- Atlas AX0660230830000013Steris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam9 reports
- AMSCO AMSCO 600 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam8 reports
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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