STERIZONE® VP4 Sterilizer 44000-RRecalls & reported problems
TSO3 Inc · The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690455440003), received between Jul 21, 2017 and Jul 2, 2020 — classified as 4 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (5 reports).
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.
Most reported problems
Device problems
- Device Reprocessing Problem5
- Degraded4
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method2
- Device Emits Odor1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement5
- Caustic/Chemical Burns3
- Skin Irritation3
- Burning Sensation1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2020Device Reprocessing Problem; Degraded; Device Reprocessing Problem; Degraded
THE USER FACILITY REPORTED THAT THE MASK STRAPS ARE EXPERIENCING DEGRADATION AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10224433 ↗MalfunctionJul 2, 2020Device Reprocessing Problem; Degraded; Device Reprocessing Problem; Degraded
THE USER FACILITY REPORTED THAT THE MASK STRAPS ARE EXPERIENCING DEGRADATION AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10223960 ↗MalfunctionJul 2, 2020Device Reprocessing Problem; Device Emits Odor; Device Reprocessing Problem; Device Emits Odor
THE USER FACILITY REPORTED THAT THE STERILIZER LEFT A STRONG SMELL OF RESIDUE ON THE MASKS AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10223950 ↗MalfunctionJul 2, 2020Device Reprocessing Problem; Degraded; Device Reprocessing Problem; Degraded
THE USER FACILITY REPORTED THAT THE STERILIZER LEFT A STRONG SMELL OF RESIDUE ON THE MASKS AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10223949 ↗MalfunctionJul 2, 2020Device Reprocessing Problem; Degraded; Device Reprocessing Problem; Degraded
THE USER FACILITY REPORTED THAT AFTER REPROCESSING OF THE MASKS, IT WAS FOUND THAT 8 MASKS HAD BROKEN BANDS. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10223858 ↗InjuryJul 21, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A USER OF THE DEVICE EXPERIENCED SLIGHT BURN/CHEMICAL IRRITATION ON HER HAND. THERE WAS NO REPORT OF A MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.
Patient problems: Caustic/Chemical Burns; Skin Irritation
MAUDE report 6734048 ↗InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A USER OF THE DEVICE EXPERIENCED SLIGHT BURN/CHEMICAL IRRITATION ON HER HAND. THERE WAS NO REPORT OF A MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.
Patient problems: Caustic/Chemical Burns; Skin Irritation
MAUDE report 6734047 ↗InjuryJul 21, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A USER OF THE DEVICE, UPON RELOADING A CART WHILE GETTING READY TO LOAD THE MACHINE, GOT A BURNING SENSATION COMING FROM UNDER THE GLOVES, REMOVED THEM AND WASHED HER HANDS. THERE WAS NO REPORT OF A MEDICAL EVALUATION OR MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.
Patient problems: Caustic/Chemical Burns; Skin Irritation
MAUDE report 6734033 ↗InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A USER OF THE DEVICE, UPON RELOADING A CART WHILE GETTING READY TO LOAD THE MACHINE, GOT A BURNING SENSATION COMING FROM UNDER THE GLOVES, REMOVED THEM AND WASHED HER HANDS. THERE WAS NO REPORT OF A MEDICAL EVALUATION OR MEDICAL TREATMENT ASSOCIATED WITH THE ALLEGED EVENT.
Patient problems: Burning Sensation
MAUDE report 6734026 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.