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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All Sterilizer, chemical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.