Revital-Ox Resert 4455AWRecalls & reported problems
Steris Corporation · Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not suitable or available. It is for use in both manual soaking and automated endoscope processors. It must be used with Revital-Ox RESERT R60 Solution Test Strips. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995095017), received between Aug 18, 2022 and Jun 18, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fire” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1605-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fire1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED VIA A CHEMTREC REPORT THAT DURING A PATIENT PROCEDURE, LIQUID WAS OBSERVED IN THE PROBE BAG. USER FACILITY PERSONNEL WERE CONCERNED THAT THE LIQUID COULD BE REVITAL-OX RESERT DISINFECTANT. USER FACILITY PERSONNEL CONTACTED POISON CONTROL AND ELECTED TO PROCEED WITH THE PROCEDURE. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564029 ↗MalfunctionJan 17, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT NUMBER MW5148516 THAT THEIR TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) PROBES THAT HAD BEEN REPROCESSED WITH REVITAL-OX RESERT HIGH LEVEL DISINFECTANT HAD AN UNKNOWN WHITE RESIDUE SUBSTANCE AROUND THEM AFTER MULTIPLE DAYS OF BEING STORED IN A PROBE CABINET. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531238 ↗MalfunctionAug 18, 2022Fire; Fire
THE USER FACILITY REPORTED THAT A CONTAINER OF REVITAL-OX RESERT HIGH LEVEL DISINFECTANT CAUGHT FIRE AS IT WAS PLACED ON A WARMING MAT. THE FIRE WAS EXTINGUISHED WITH A FIRE EXTINGUISHER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15253146 ↗
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- CIDEX™ 20390Advanced Sterilization Products Services Inc. · Sterilant, medical devices33 reports
- Rapicide High Level Disinfectant and Sterilant ML02-0059Medivators Inc. · Sterilant, Medical Devices6 reports
- SYSTEM 1 endoCorporation Steris Canada · Sterilant, medical devices5 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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