AMSCO V-PRORecalls & reported problems across all models
Steris Mexico, S. de R.L. de C.V. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of AMSCO V-PRO by Steris Mexico, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2021 and May 7, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (6 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
AMSCO V-PRO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 26, 2018Terminated
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
Z-2959-2018 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗
Most reported AMSCO V-PRO problems
Device problems
- Use of Device Problem6
- Fire5
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
Patient problems
- Burn(s)7
- No Clinical Signs, Symptoms or Conditions7
- Burning Sensation1
AMSCO V-PRO models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMSCO V-PRO maXSterilizer, chemical1 recall2 reports
- Amsco V-PRO 1Sterilizer, chemical1 recall0 reports
- Amsco V-PRO 1 PlusSterilizer, chemical1 recall0 reports
- AMSCO V-PRO V-PRO maXSterilizer, chemical11 reports
- AMSCO V-PRO V-PRO maXSterilizer, chemical2 reports
Recent AMSCO V-PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR HANDS AFTER HANDLING A TRAY THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 25116249 ↗MalfunctionDec 16, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821270 ↗MalfunctionNov 14, 2025Fire; Leak/Splash; Fire; Leak/Splash
THE DEALER REPORTED THAT ONE OF THEIR CUSTOMER'S V-PRO MAX STERILIZERS CAUGHT FIRE. THE DAMAGE SUSTAINED WAS CONTAINED WITHIN THE STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557026 ↗MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER HANDING INSTRUMENTS THAT WERE PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 22919841 ↗MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED BURNS WHILE REMOVING VAPROX HC STERILANT CUPS FROM THEIR V-PRO MAX STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 22740298 ↗MalfunctionMay 27, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089072 ↗MalfunctionMay 16, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037802 ↗MalfunctionNov 1, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR ARM AFTER HANDING A WRAP THAT WAS PREVIOUSLY PROCESSED ITEM IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.
Patient problems: Burning Sensation
MAUDE report 20589030 ↗MalfunctionJun 28, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT FIVE EMPLOYEES OBTAINED A BURN TO THEIR HANDS AFTER HANDLING AN INSTRUMENT PACK THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 19634953 ↗MalfunctionJun 17, 2024Fire; Fire
THE USER FACILITY REPORTED THAT DURING A CYCLE, THEIR V-PRO MAX STERILIZER CAUGHT ON FIRE AND THE FIRE DEPARTMENT WAS DISPATCHED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19553700 ↗MalfunctionMar 7, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A BURN ON THEIR HANDS WHILE HANDLING ITEMS THAT WERE PROCESSED IN A V-PRO MAX STERILIZER. THE EMPLOYEE WAS TAKEN TO THE EMERGENCY ROOM AND RECEIVED MEDICAL TREATMENT (BANDAGE).
Patient problems: Burn(s)
MAUDE report 18856945 ↗MalfunctionSep 1, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
A STERIS SERVICE TECHNICIAN WAS PERFORMING SERVICE ON A V-PRO MAX STERILIZER WHICH HAD PREVIOUSLY BEEN REMOVED FROM USE AND TAGGED OUT FOR REPAIRS. THE TECHNICIAN TEMPORARILY LEFT THE USER FACILITY TO OBTAIN ADDITIONAL SERVICE PARTS WHEN USER FACILITY PERSONNEL REPORTED A BURNING SMELL BEGAN TO EMIT FROM THE UNIT. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17670012 ↗MalfunctionJun 7, 2023Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR LEFT HAND WHILE HANDLING ITEMS THAT WERE PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT (OINTMENT).
Patient problems: Burn(s)
MAUDE report 17078457 ↗MalfunctionNov 11, 2021Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR RIGHT HAND WHILE HANDLING ITEMS THAT WERE PROCESSED IN A V-PRO MAX STERILIZER. MEDICAL TREATMENT WAS ADMINISTERED (OINTMENT); AND THE EMPLOYEE RETURNED TO WORK.
Patient problems: Burn(s)
MAUDE report 12798357 ↗MalfunctionAug 26, 2021Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12369796 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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