AMSCO AMSCO 400 Steam Sterilizer (REF SR2121213011)Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The AMSCO 400 Series 36H Prevacuum Steam Sterilizer with 36-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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995209841), received between Jun 18, 2026 and Jun 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Mechanical Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO HER ARM WHILE REMOVING AN ITEM SHE HAD PLACED INTO THEIR AMSCO 400 STERILIZER. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 25552946 ↗
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 · TerminatedEvolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
- 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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