AMSCORecalls & reported problems across all models
Steris Mexico, S. de R.L. de C.V. · 45 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 116
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 45 models of AMSCO by Steris Mexico, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2021 and Sep 30, 2026 — classified as 3 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (72 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AMSCO problems
Device problems
- Leak/Splash72
- Detachment of Device or Device Component7
- Insufficient Device Problem Information7
- Mechanical Problem5
- Use of Device Problem5
- Adverse Event Without Identified Device or Use Problem4
- Smoking4
- Failure to Align2
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- Burn(s)10
- Pain5
- Abrasion1
- Bruise/Contusion1
- Dizziness1
- Ear Pain1
- Eye Infections1
AMSCO models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam11 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam9 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam8 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam7 reports
- AMSCO 16CSterilizer, steam6 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam6 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam5 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam5 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam4 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam4 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam3 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam3 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam3 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam3 reports
- AMSCO 20CSterilizer, steam2 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam2 reports
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam2 reports
- AMSCO 20Sterilizer, steam1 report
- AMSCO 36HSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 600 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
- AMSCO AMSCO 400 Steam SterilizerSterilizer, steam1 report
Recent AMSCO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951773 ↗MalfunctionSep 24, 2026Leak/Splash
The user facility reported that their AMSCO 400 Sterilizer was leaking water and emitting a ¿burning odor¿. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882026 ↗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 ↗InjurySep 10, 2026Unintended Movement
Patient problems: Burn(s)
MAUDE report 50721625 ↗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 ↗MalfunctionSep 1, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551728 ↗MalfunctionAug 28, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497973 ↗MalfunctionAug 26, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450821 ↗MalfunctionAug 19, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328462 ↗MalfunctionAug 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144944 ↗MalfunctionJul 13, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25802367 ↗MalfunctionJun 25, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A CYCLE THEIR AMSCO 400 STERILIZER LEAKED STEAM SUBSEQUENTLY CAUSING THE FACILITY'S FIRE ALARM TO GO OFF. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627071 ↗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 ↗MalfunctionMay 15, 2026Leak/Splash
THE USER FACILITY REPORTED WATER AND STEAM LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25188546 ↗MalfunctionMay 14, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A CYCLE THEIR AMSCO 400 STERILIZER LEAKED STEAM SUBSEQUENTLY CAUSING THE FACILITY'S FIRE ALARM TO GO OFF. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173962 ↗
Other Steris Mexico, S. de R.L. de C.V. products
All Steris Mexico, S. de R.L. de C.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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