V-PRO S2Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The V-PRO s2 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995164096), received between Oct 30, 2025 and Sep 2, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (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
- Device Handling Problem1
- Insufficient Device Problem Information1
- Leak/Splash1
- Smoking1
- Use of Device Problem1
Patient problems
- Burn(s)2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Device Handling Problem
The user facility reported that two employees sustained a burn after handling a load processed in the V-PRO s2 Sterilizer. User facility personnel stated that one of the employees subject of the reported event sought medical treatment however the type of treatment that may have been administered was not disclosed.
Patient problems: Burn(s)
MAUDE report 50567470 ↗MalfunctionJan 21, 2026Leak/Splash
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO S2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132894 ↗MalfunctionJan 9, 2026Use of Device Problem; Insufficient Device Problem Information
USER FACILITY PERSONNEL STATED 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: Burn(s)
MAUDE report 24026012 ↗MalfunctionOct 30, 2025Smoking; Smoking
THE USER FACILITY REPORTED THAT THE ROOM WHERE THEIR V-PRO S2 STERILIZER IS LOCATED WAS "SMOKY". NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424553 ↗
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- 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.