VAPROX PB007Recalls & reported problems
Steris Corporation · The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide and is used with V-PRO Low Temperature Sterilization Systems. The net contents are 113 mL per cup. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995089160), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K062297, K083097, K102330, K102394, K111810, K112760, K112813, K120632, K131120, K140498, K160433, K162413, K172319, K172754, K182568, K190103, K190917, K222093, K223476, K233065); 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A "BURN" TO THEIR HANDS FROM HANDLING VAPROX CARTRIDGES. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 18990133 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062297, K083097, K102330, K102394, K111810, K112760, K112813, K120632, K131120, K140498, K160433, K162413, K172319, K172754, K182568, K190103, K190917, K222093, K223476, K233065. 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)
- Z-3041-2011 · Aug 1, 2011 · TerminatedAmsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Ste
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.