AMSCO V-PRO maXRecalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The Amsco V-PRO maX Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities. · 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
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995151997), received between May 27, 2025 and May 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (1 report).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jul 26, 2018Terminated
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
Z-2959-2018 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fire1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR HANDS AFTER HANDLING A TRAY THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 25116249 ↗MalfunctionMay 27, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089072 ↗
Other Sterilizer, chemical devices
- STERRAD™ 10104Advanced Sterilization Products Services Inc. · Sterilizer, chemical259 reports
- STERRAD™ 10104-007Advanced Sterilization Products Services Inc. · Sterilizer, chemical153 reports
- STERRAD NX™ 10033Advanced Sterilization Products Services Inc. · Sterilizer, chemical132 reports
- STERRAD™ 10104-003Advanced Sterilization Products Services Inc. · Sterilizer, chemical92 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
- V-PRO max 2Steris Mexico, S. de R.L. de C.V. · Sterilizer, chemical45 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page