VAPROX PB011Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00724995153090), received between Jun 2, 2022 and Jun 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT AN EMPLOYEE NOTICED A BURNING SENSATION ON THEIR THUMB WHILE HANDLING A LEAKING CARTRIDGE OF VAPROX HC STERILANT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 25394698 ↗
• MalfunctionApr 9, 2026Leak/Splash

  THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN ON THEIR FINGER WHILE HANDLING A LEAKING CARTON OF VAPROX HC STERILANT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Burn(s)

  MAUDE report 24830315 ↗
• MalfunctionJan 22, 2026Device Handling Problem

  THE USER FACILITY REPORTED THAT A BOTTLE OF VAPROX HC STERILANT LEAKED AND CONTACTED AN EMPLOYEE'S HAND. THE EMPLOYEE SOUGHT MEDICAL TREATMENT, HOWEVER NO MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Pain

  MAUDE report 24147556 ↗
• MalfunctionJun 5, 2025Fire; Fire

  THE SHIPPING PERSONNEL REPORTED VIA CHEMTREC REPORT THAT A FIRE WAS OBSERVED ON THEIR SHIPPING TRUCK WHILE STORING VAPROX HC STERILANT IN THE TRUCK'S CAB. THE FIRE DEPARTMENT WAS DISPATCHED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153398 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A BURN AFTER A CUP OF VAPROX HC STERILANT LEAKED ONTO THEIR HAND. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 20757575 ↗
• MalfunctionOct 3, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED PAIN TO THEIR HANDS AFTER CHANGING A CUP OF VAPROX HC STERILANT. THE EMPLOYEE WASHED THEIR HANDS WITH WATER AND CONTINUED WORKING. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Pain

  MAUDE report 20359925 ↗
• MalfunctionSep 26, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE OUTSIDE PACKAGING FOR THEIR VAPROX HC STERILANT WAS "DAMAGED" AND "WET". AN EMPLOYEE PROCEEDED TO OPEN THE PACKAGING AND OBSERVED A VAPROX HC STERILANT CUP TO BE LEAKING. THE EMPLOYEE PROCEEDED TO HANDLE THE DAMAGED CUP AND OBTAINED A "BURN" TO THEIR THUMB. IT IS UNKNOWN IS MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Skin Discoloration

  MAUDE report 20312472 ↗
• MalfunctionMay 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY EMPLOYEE REPORTED VIA CHEMTREC REPORT THAT WHILE HE WAS "MOVING A TRAY OF VAPROX HC STERILANT" SOME OF THE PRODUCT GOT ON HIS LEFT HAND CAUSING A "WHITE BURN" ON HIS FINGERS. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 19231630 ↗
• MalfunctionMar 7, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED THAT AN EMPLOYEE HAD OPENED A CASE OF VAPROX STERILANT CARTRIDGES AND UPON REMOVING THE PRODUCT FROM THE CASE THE EMPLOYEE OBTAINED DISCOLORATION TO THEIR HANDS. A SECOND EMPLOYEE ALSO EXPERIENCED DISCOLORATION TO THEIR HANDS. BOTH EMPLOYEES WENT TO THE FACILITY'S EMERGENCY ROOM.

  Patient problems: Skin Discoloration

  MAUDE report 18857343 ↗
• MalfunctionJan 5, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN FROM VAPROX STERILANT.

  Patient problems: Burn(s)

  MAUDE report 18453784 ↗
• MalfunctionJan 13, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE USER FACILITY REPORTED THAT UPON OPENING A CASE OF VAPROX HC STERILANT AN EMPLOYEE STATED SHE FELT A BURNING FEELING ON HER FINGER. THE EMPLOYEE WASHED HER FINGER WITH WATER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 16158623 ↗
• MalfunctionJun 2, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE USER FACILITY REPORTED TO ANVISA THAT THEIR VPRO MAX 2 STERILIZER DID NOT RECOGNIZE A VAPROX HC STERILANT CUP UPON INSERTION. THE USER FACILITY THEN INSERTED A DIFFERENT VAPROX HC STERILANT CUP FROM THE SAME LOT AND NO ISSUES WERE NOTED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578391 ↗