V-PRO max 2 (REF VP50001101)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
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995152673), received between Nov 29, 2022 and Jan 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
- Use of Device Problem1
Patient problems
- Burn(s)2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Leak/Splash
THE USER FACILITY REPORTED THAT OIL WAS LEAKING FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24089468 ↗MalfunctionMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN WHILE REMOVING AN EMPTY STERILANT CUP FROM THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL ATTENTION HOWEVER, IT IS UNKNOWN WHAT, IF ANY TREATMENT THAT MAY HAVE BEEN RECEIVED.
Patient problems: Burn(s)
MAUDE report 21712984 ↗MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED BURNS WHILE HANDLING ITEMS THAT WERE PROCESSED IN V-PRO MAX 2 STERILIZERS. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 15879875 ↗
Other Sterilizer, chemical devices
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- STERRAD NX™ 10033Advanced Sterilization Products Services Inc. · Sterilizer, chemical132 reports
- STERRAD™ 10104-003Advanced Sterilization Products Services Inc. · Sterilizer, chemical92 reports
- 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.