AMSCO AMSCO 600 Steam Sterilizer (REF EF1301142)Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The AMSCO 600 Vacuum 26 x 26 x 63-inch Electric Single Door Slide Recessed is designed for sterilization of heat and moisture-stable 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00724995179632), received between Mar 16, 2023 and Sep 11, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
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/Splash4
- Fire1
- Mechanical Problem1
- No Apparent Adverse Event1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Mechanical Problem
The user facility reported that there was a burning odor emitting from their AMSCO 600 Sterilizer. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732251 ↗MalfunctionApr 22, 2026Smoking
THE USER FACILITY REPORTED A SMALL AMOUNT OF SMOKE EMITTED FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956445 ↗MalfunctionDec 19, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER LEAKED STEAM AND WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849353 ↗MalfunctionDec 13, 2024Fire; Fire
THE USER FACILITY REPORTED OBSERVING A SMALL FLAME ON THEIR AMSCO 600 STERILIZER. THE FLAME WAS QUICKLY EXTINGUISHED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20929417 ↗MalfunctionJul 25, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH REPORTS MW5155875, MW5155876 AND MW5155877 THAT "PMS OF 3 STERILIZERS WERE CLOSED OUTSIDE THE MONTH +/- 10 DAY WINDOW FOR COMPLETING SCHEDULED PLANNED MAINTENANCE. THIS WAS DUE TO THE CONTRACTED OEMS INABILITY TO PRODUCE THE PM KITS NEEDED FOR THE EQUIPMENT DUE FOR PM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19828618 ↗MalfunctionJun 13, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19534380 ↗MalfunctionNov 1, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM TWO OF THEIR AMSCO 600 STERILIZERS ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18050380 ↗MalfunctionMar 16, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16554704 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page