Revital-Ox 4453AWRecalls & reported problems
Steris Corporation · Revital-Ox PAA HLD Solution Part A is used Revital-Ox PAA HLD Part B and the enspire 300 Series Automated Endoscope Reprocessor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00724995216924), received between Jul 16, 2026 and Jul 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Leak/Splash
Patient problems: Chemical Exposure
MAUDE report 25846649 ↗
Other Sterilant, medical devices devices
- Revital-Ox Resert 4455AWSteris Corporation · Sterilant, medical devices1 recall3 reports
- McKesson 68-101400Mckesson Medical-Surgical Inc. · Sterilant, Medical Devices1 recall0 reports
- MetriCide 10-1400Metrex Research, LLC · Sterilant, medical devices1 recall0 reports
- MetriCide28 10-2800Metrex Research, LLC · Sterilant, medical devices1 recall0 reports
- McKesson 341Mckesson Medical-Surgical Inc. · Sterilant, Medical Devices1 recall0 reports
- McKesson 68-102800Mckesson Medical-Surgical Inc. · Sterilant, Medical Devices1 recall0 reports
- CIDEX™ 20390Advanced Sterilization Products Services Inc. · Sterilant, medical devices33 reports
- Rapicide High Level Disinfectant and Sterilant ML02-0059Medivators Inc. · Sterilant, Medical Devices6 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 18, 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