AMSCO V-PRO V-PRO maX (REF VP30001101)Recalls & 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
All models of AMSCO V-PRO (5)
Data updated Oct 16, 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 00724995000028), received between Nov 11, 2021 and Mar 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K102330, K112760, K112813, K120632, K131120, K160433, K162413, K172319, K172754, K190103); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionMar 7, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A BURN ON THEIR HANDS WHILE HANDLING ITEMS THAT WERE PROCESSED IN A V-PRO MAX STERILIZER. THE EMPLOYEE WAS TAKEN TO THE EMERGENCY ROOM AND RECEIVED MEDICAL TREATMENT (BANDAGE).
Patient problems: Burn(s)
MAUDE report 18856945 ↗MalfunctionNov 11, 2021Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR RIGHT HAND WHILE HANDLING ITEMS THAT WERE PROCESSED IN A V-PRO MAX STERILIZER. MEDICAL TREATMENT WAS ADMINISTERED (OINTMENT); AND THE EMPLOYEE RETURNED TO WORK.
Patient problems: Burn(s)
MAUDE report 12798357 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K102330, K112760, K112813, K120632, K131120, K160433, K162413, K172319, K172754, K190103. One submission often covers many models, so check the product and lot details in each record.
- Z-2959-2018 · Jul 26, 2018 · TerminatedAMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC S
- Z-0772-2018 · Sep 28, 2017 · TerminatedV-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
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 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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