V-PRO max 2 (REF VP50002101)Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The V-PRO maX 2 Low Temperature Sterilization System is used in the terminal sterilization of properly prepared, cleaned, rinsed and dried medical devices utilizing VAPROX HC Sterilant. · Class 2
Quick summary
This Steris V-PRO maX 2 is a low-temperature sterilizer that uses vaporized hydrogen peroxide to process medical instrument trays. The 43 reports mostly describe burns to staff handling wet or hot instrument packs, along with leaking or splashing liquid, oil leaks, a burning odor, and two reports of the unit catching fire during a cycle. There are 2 injuries and no deaths. No recalls name this device, and the number of reports over the past 12 months (11) is close to the 12 before that (12).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00724995158354), received between Aug 11, 2021 and Sep 25, 2026 — classified as 4 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (17 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem17
- Leak/Splash10
- Device Handling Problem4
- Insufficient Device Problem Information4
- Improper or Incorrect Procedure or Method3
- Device Emits Odor2
- Fire2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)28
- No Clinical Signs, Symptoms or Conditions11
- Laceration(s)2
- Caustic/Chemical Burns1
- Eye Irritation1
- Headache1
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Improper or Incorrect Procedure or Method
The user facility reported that two employees obtained a burn to their hands after handling an instrument pack that was processed in their V-PRO maX 2 Sterilizer. It is unknown if medical treatment was sought or administered.
Patient problems: Burn(s)
MAUDE report 50895552 ↗InjurySep 21, 2026Improper or Incorrect Procedure or Method
The user facility reported that an employee obtained burns and an allergic reaction after handling a wrapped tray that was processed in their V-PRO maX 2 Sterilizer. User facility personnel stated the employee's hands began to swell, and the employee subsequently experienced respiratory irritation. The employee subject of the reported event sought medical treatment at the ER. The user facility did not disclose the type of treatment that may have been administered.
Patient problems: Caustic/Chemical Burns; Hypersensitivity/Allergic reaction
MAUDE report 50836760 ↗InjuryAug 4, 2026Sharp Edges
Patient problems: Laceration(s)
MAUDE report 50128664 ↗InjuryJul 27, 2026Insufficient Device Problem Information
The user facility reported that employees obtained a burn to their hands after handling instrument packs processed in their V-PRO maX 2 Sterilizers. Report of injury. It is unknown if medical treatment was sought or administered.
Patient problems: Burn(s)
MAUDE report 50012167 ↗MalfunctionJun 19, 2026Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR HAND AFTER HANDLING AN INSTRUMENT TRAY THAT WAS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 25564211 ↗MalfunctionMar 19, 2026Leak/Splash
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643198 ↗MalfunctionFeb 26, 2026Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER CAUGHT FIRE DURING A CYCLE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461662 ↗MalfunctionFeb 26, 2026Device Emits Odor
THE USER FACILITY REPORTED THAT THERE WAS A BURNING ODOR EMITTING FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24459556 ↗MalfunctionFeb 13, 2026Leak/Splash
THE USER FACILITY REPORTED THAT ONE OF THEIR EMPLOYEES RECEIVED A BURN AFTER COMING IN CONTACT WITH A WET TRAY THAT WAS PROCESSED IN THE V-PRO MAX 2 STERILIZER. THE EMPLOYEE WENT TO THE ER, BUT IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 24337685 ↗MalfunctionJan 8, 2026Device Handling Problem
THE USER FACILITY REPORTED THAT AFTER AN INSTRUMENT FELL UNDERNEATH THEIR V-PRO MAX 2 STERILIZER, AN EMPLOYEE MOVED THE UNIT TO RETRIEVE THE INSTRUMENT AND OBTAINED A CUT ON THEIR HAND. THE EMPLOYEE WASHED THEIR HANDS, APPLIED BANDAGES, AND RETURNED TO WORK.
Patient problems: Laceration(s)
MAUDE report 24005701 ↗MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HANDS AFTER UNLOADING AN INSTRUMENT FROM THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT, HOWEVER IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 23782898 ↗MalfunctionNov 26, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED BURNS TO THEIR HANDS AFTER HANDLING SCOPES THAT WERE PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEES RINSED THEIR HANDS WITH WATER AND CONTINUED WORKING.
Patient problems: Burn(s)
MAUDE report 23658446 ↗MalfunctionNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED A BURN AFTER UNLOADING THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 23657233 ↗MalfunctionSep 12, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039521 ↗MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE FRONT PANEL TO THEIR V-PRO MAX 2 STERILIZER FELL ON AN EMPLOYEE'S FOOT. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, BUT IT IS UNKNOWN WHICH TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 22586667 ↗MalfunctionJul 17, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT EMPLOYEES EXPERIENCED DIFFICULTY "BREATHING" AND "SEEING" FROM OIL MIST THAT WAS EMITTING FROM THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Eye Irritation; Upper Respiratory Tract Irritation
MAUDE report 22529477 ↗MalfunctionJul 2, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER WAS LEAKING OIL ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22386016 ↗MalfunctionJun 20, 2025Device Handling Problem; Device Handling Problem
THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED "WHITE STAINING" TO THEIR FINGERS WHILE UNLOADING INSTRUMENTS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEES CONTINUED WORKING. NO REPORT OF INJURY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301302 ↗MalfunctionJun 12, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT OIL WAS LEAKING FROM THEIR V-PRO MAX 2 STERILIZER AND SMOKE EMITTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192912 ↗MalfunctionJun 11, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187084 ↗MalfunctionApr 28, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER HANDLING ITEMS THAT WERE PROCESSED IN THEIR V-PRO MAX 2 STERILIZERS. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.
Patient problems: Burn(s)
MAUDE report 21922316 ↗MalfunctionMar 6, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER WAS EMITTING "SMOKE" AND LEAKING OIL ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536552 ↗MalfunctionFeb 7, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN ON THEIR HANDS AFTER HANDLING AN INSTRUMENT PACK THAT WAS PROCESSED THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS RECEIVED.
Patient problems: Burn(s)
MAUDE report 21335312 ↗MalfunctionJan 9, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR FINGERS AFTER HANDLING ITEMS PROCESSED IN THEIR V-PRO MAX 2 STERILIZERS. IT WAS REPORTED MEDICAL TREATMENT WAS ADMINISTERED, BUT THE DETAILS OF THIS TREATMENT WERE NOT PROVIDED.
Patient problems: Burn(s)
MAUDE report 21111658 ↗MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A BURN AFTER OPENING A PACK THAT WAS PREVIOUSLY PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE RINSED THEIR HANDS WITH WATER AND CONTINUED WORKING.
Patient problems: Burn(s)
MAUDE report 20668742 ↗
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- AMSCO V-PRO maXSteris Mexico, S. de R.L. de C.V. · Sterilizer, chemical1 recall2 reports
- Amsco V-PRO 1 PlusSteris Mexico, S. de R.L. de C.V. · Sterilizer, chemical1 recall0 reports
- V-PRO 60Steris Mexico, S. de R.L. de C.V. · Sterilizer, chemical1 recall0 reports
- Amsco V-PRO 1Steris Mexico, S. de R.L. de C.V. · Sterilizer, chemical1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.