V-PRORecalls & reported problems across all models
Steris Mexico, S. de R.L. de C.V. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 5 models of V-PRO by Steris Mexico, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2021 and Sep 25, 2026 — classified as 5 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (21 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
V-PRO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 26, 2018Terminated
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
Z-2959-2018 · Root cause: Software design · Recall details · FDA record ↗
Most reported V-PRO problems
Device problems
- Use of Device Problem21
- Leak/Splash12
- Device Handling Problem5
- Insufficient Device Problem Information5
- Improper or Incorrect Procedure or Method3
- Adverse Event Without Identified Device or Use Problem2
- Device Emits Odor2
- Fire2
Patient problems
- Burn(s)34
- No Clinical Signs, Symptoms or Conditions14
- Laceration(s)2
- Caustic/Chemical Burns1
- Eye Irritation1
- Headache1
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
V-PRO models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- V-PRO 60Sterilizer, chemical1 recall0 reports
- V-PRO max 2Sterilizer, chemical45 reports
- V-PRO S2Sterilizer, chemical4 reports
- V-PRO max 2Sterilizer, chemical3 reports
- V-PRO max 2Sterilizer, chemical2 reports
Recent V-PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Improper or Incorrect Procedure or Method
The user facility reported that two employees obtained a burn to their hands after handling an instrument pack that was processed in their V-PRO maX 2 Sterilizer. It is unknown if medical treatment was sought or administered.
Patient problems: Burn(s)
MAUDE report 50895552 ↗InjurySep 21, 2026Improper or Incorrect Procedure or Method
The user facility reported that an employee obtained burns and an allergic reaction after handling a wrapped tray that was processed in their V-PRO maX 2 Sterilizer. User facility personnel stated the employee's hands began to swell, and the employee subsequently experienced respiratory irritation. The employee subject of the reported event sought medical treatment at the ER. The user facility did not disclose the type of treatment that may have been administered.
Patient problems: Caustic/Chemical Burns; Hypersensitivity/Allergic reaction
MAUDE report 50836760 ↗InjurySep 2, 2026Device Handling Problem
The user facility reported that two employees sustained a burn after handling a load processed in the V-PRO s2 Sterilizer. User facility personnel stated that one of the employees subject of the reported event sought medical treatment however the type of treatment that may have been administered was not disclosed.
Patient problems: Burn(s)
MAUDE report 50567470 ↗InjuryAug 4, 2026Sharp Edges
Patient problems: Laceration(s)
MAUDE report 50128664 ↗InjuryJul 27, 2026Insufficient Device Problem Information
The user facility reported that employees obtained a burn to their hands after handling instrument packs processed in their V-PRO maX 2 Sterilizers. Report of injury. It is unknown if medical treatment was sought or administered.
Patient problems: Burn(s)
MAUDE report 50012167 ↗MalfunctionJun 19, 2026Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR HAND AFTER HANDLING AN INSTRUMENT TRAY THAT WAS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 25564211 ↗MalfunctionMar 19, 2026Leak/Splash
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643198 ↗MalfunctionFeb 26, 2026Fire
THE USER FACILITY REPORTED THAT THEIR V-PRO MAX 2 STERILIZER CAUGHT FIRE DURING A CYCLE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461662 ↗MalfunctionFeb 26, 2026Device Emits Odor
THE USER FACILITY REPORTED THAT THERE WAS A BURNING ODOR EMITTING FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24459556 ↗MalfunctionFeb 13, 2026Leak/Splash
THE USER FACILITY REPORTED THAT ONE OF THEIR EMPLOYEES RECEIVED A BURN AFTER COMING IN CONTACT WITH A WET TRAY THAT WAS PROCESSED IN THE V-PRO MAX 2 STERILIZER. THE EMPLOYEE WENT TO THE ER, BUT IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 24337685 ↗MalfunctionJan 21, 2026Leak/Splash
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO S2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132894 ↗MalfunctionJan 15, 2026Leak/Splash
THE USER FACILITY REPORTED THAT OIL WAS LEAKING FROM THEIR V-PRO MAX 2 STERILIZER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24089468 ↗MalfunctionJan 9, 2026Use of Device Problem; Insufficient Device Problem Information
USER FACILITY PERSONNEL STATED THE EMPLOYEE SUBJECT OF THE REPORTED EVENT SOUGHT MEDICAL TREATMENT AT THE ER. THE USER FACILITY DID NOT DISCLOSE THE TYPE OF TREATMENT THAT MAY HAVE BEEN ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 24026012 ↗MalfunctionJan 8, 2026Device Handling Problem
THE USER FACILITY REPORTED THAT AFTER AN INSTRUMENT FELL UNDERNEATH THEIR V-PRO MAX 2 STERILIZER, AN EMPLOYEE MOVED THE UNIT TO RETRIEVE THE INSTRUMENT AND OBTAINED A CUT ON THEIR HAND. THE EMPLOYEE WASHED THEIR HANDS, APPLIED BANDAGES, AND RETURNED TO WORK.
Patient problems: Laceration(s)
MAUDE report 24005701 ↗MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HANDS AFTER UNLOADING AN INSTRUMENT FROM THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT, HOWEVER IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 23782898 ↗
Other Steris Mexico, S. de R.L. de C.V. products
All Steris Mexico, S. de R.L. de C.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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