V-PRO max 2 (REF VP50003101)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995158361), received between Dec 28, 2023 and Jan 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 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 Problem2
Patient problems
- Burn(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN WHILE REMOVING A PROCESSED PACK FROM A V-PRO MAX 2 STERILIZER AFTER A COMPLETED CYCLE. THE EMPLOYEE WAS TAKEN TO THE EMERGENCY ROOM AND RECEIVED MEDICAL TREATMENT (OINTMENT).
Patient problems: Burn(s)
MAUDE report 18460623 ↗MalfunctionDec 28, 2023Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED VIA PMDA REPORT THAT AN EMPLOYEE OBTAINED A BURN ON THEIR FINGER WHEN HANDLING A POUCH AFTER IT WAS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE WASHED THEIR HANDS AND RETURNED TO WORK. NO REPORT OF PROCEDURE DELAY.
Patient problems: Burn(s)
MAUDE report 18409138 ↗
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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