AMSCO AMSCO 400 Steam Sterilizer (REF SR3201110111)Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The AMSCO 400 Series 20S Steam Flush Pressure Pulse Steam Sterilizer 38-inch Single Door Cabinet 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995210991), received between Jan 19, 2023 and Jan 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Leak/Splash
THE USER FACILITY REPORTED THAT STEAM AND WATER LEAKED FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24089486 ↗MalfunctionJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING OF THEIR AMSCO 400 STERILIZER.
Patient problems: Inflammation
MAUDE report 16204459 ↗
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
- AMSCO AMSCO 400 Steam SterilizerSteris Mexico, S. de R.L. de C.V. · Sterilizer, steam11 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
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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