AMSCO 36HRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995151669), received between Mar 26, 2025 and Mar 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE LOWER PANEL ON THEIR AMSCO 400 STEAM STERILIZER FELL AND CONTACTED THE EMPLOYEE. THE EMPLOYEE HAD TO USE A FOOT BRACE AS A RESULT.
Patient problems: Pain
MAUDE report 21700848 ↗
Other Sterilizer, steam devices
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- 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.