V-PRO 60Recalls & reported problems
Steris Mexico, S. de R.L. de C.V. · The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities. · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K140498, K162413, K172319, K182568, K190917, K222849); 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. How this data works · Data updated Oct 13, 2026.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140498, K162413, K172319, K182568, K190917, K222849. One submission often covers many models, so check the product and lot details in each record.
- 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
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.