AMSCO V-PRO V-PRO maX (REF VP30002101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00724995206987), received between Aug 26, 2021 and Dec 16, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fire” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K102330, K112760, K112813, K120632, K131120, K160433, K162413, K172319, K172754, K190103); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Fire; Fire

  THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821270 ↗
• MalfunctionNov 14, 2025Fire; Leak/Splash; Fire; Leak/Splash

  THE DEALER REPORTED THAT ONE OF THEIR CUSTOMER'S V-PRO MAX STERILIZERS CAUGHT FIRE. THE DAMAGE SUSTAINED WAS CONTAINED WITHIN THE STERILIZER. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557026 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER HANDING INSTRUMENTS THAT WERE PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 22919841 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED BURNS WHILE REMOVING VAPROX HC STERILANT CUPS FROM THEIR V-PRO MAX STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 22740298 ↗
• MalfunctionMay 16, 2025Fire; Fire

  THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037802 ↗
• MalfunctionNov 1, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR ARM AFTER HANDING A WRAP THAT WAS PREVIOUSLY PROCESSED ITEM IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Burning Sensation

  MAUDE report 20589030 ↗
• MalfunctionJun 28, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT FIVE EMPLOYEES OBTAINED A BURN TO THEIR HANDS AFTER HANDLING AN INSTRUMENT PACK THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 19634953 ↗
• MalfunctionJun 17, 2024Fire; Fire

  THE USER FACILITY REPORTED THAT DURING A CYCLE, THEIR V-PRO MAX STERILIZER CAUGHT ON FIRE AND THE FIRE DEPARTMENT WAS DISPATCHED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553700 ↗
• MalfunctionSep 1, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  A STERIS SERVICE TECHNICIAN WAS PERFORMING SERVICE ON A V-PRO MAX STERILIZER WHICH HAD PREVIOUSLY BEEN REMOVED FROM USE AND TAGGED OUT FOR REPAIRS. THE TECHNICIAN TEMPORARILY LEFT THE USER FACILITY TO OBTAIN ADDITIONAL SERVICE PARTS WHEN USER FACILITY PERSONNEL REPORTED A BURNING SMELL BEGAN TO EMIT FROM THE UNIT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670012 ↗
• MalfunctionJun 7, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR LEFT HAND WHILE HANDLING ITEMS THAT WERE PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT (OINTMENT).

  Patient problems: Burn(s)

  MAUDE report 17078457 ↗
• MalfunctionAug 26, 2021Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102330, K112760, K112813, K120632, K131120, K160433, K162413, K172319, K172754, K190103. One submission often covers many models, so check the product and lot details in each record.

• Z-2959-2018 · Jul 26, 2018 · Terminated
  AMSCO 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 · Terminated
  V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)