AMSCO 20Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped with Prevacuum, gravity, leak test, and daily air removal test cycles and offers optional Steam Flush Pressure Pulse (SFPP) configuration. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995151652), received between Sep 9, 2026 and Sep 9, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Unintended Movement
The user facility reported that the front wheels to their Evolution Transfer Carriage did not latch properly to the sterilizer¿s docking station subsequently causing the Carriage to fall. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696781 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.