Rapicide PA High-Level DisinfectantRecalls & reported problems across all models
Medivators Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Rapicide PA High-Level Disinfectant model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 1
We found 3 models of Rapicide PA High-Level Disinfectant by Medivators Inc. in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2016 and Sep 10, 2026 — classified as 30 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (26 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Rapicide PA High-Level Disinfectant 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.
- Sep 21, 2026Open, Classified
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
Z-0156-2027 · Root cause: Process change control · Recall details · FDA record ↗
Most reported Rapicide PA High-Level Disinfectant problems
Device problems
- Leak/Splash26
- Adverse Event Without Identified Device or Use Problem13
- Insufficient Device Problem Information9
- Chemical Spillage7
- Fumes or Vapors7
- Use of Device Problem7
- Device Handling Problem5
- Device Damaged Prior to Receipt by User4
Patient problems
- Chemical Exposure32
- Burn(s)14
- No Clinical Signs, Symptoms or Conditions7
- Eye Irritation5
- Skin Discoloration5
- Burning Sensation4
- Skin Irritation3
- Sore Throat3
Rapicide PA High-Level Disinfectant models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rapicide PA High-Level Disinfectant ML02-0117Accessories, Cleaning, For Endoscope64 reports
- Rapicide PA High-Level Disinfectant ML020117Accessories, cleaning, for endoscope1 recall6 reports
- Rapicide PA High-Level Disinfectant ML02-0117Accessories, Cleaning, For Endoscope10 reports
Recent Rapicide PA High-Level Disinfectant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721691 ↗MalfunctionAug 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498790 ↗InjuryAug 13, 2026Device Handling Problem
The user facility reported while an employee was utilizing a Rapicide PA Test Strip test after a cycle, the collection container was dropped subsequently causing Rapicide PA High-Level Disinfectant to splash into the employee¿s eye. The employee flushed their eyes with water and sought treatment at the facility¿s Emergency Department.
Patient problems: Eye Irritation
MAUDE report 50238207 ↗InjuryJul 31, 2026Leak/Splash
The user facility reported that an employee came into contact with Rapicide PA High-level Disinfectant and sustained a burn. It is unknown whether medical treatment was sought or administered.
Patient problems: Burn(s)
MAUDE report 50098269 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846920 ↗MalfunctionJul 9, 2026Leak/Splash
Patient problems: Upper Respiratory Tract Irritation
MAUDE report 25771008 ↗MalfunctionJul 9, 2026Leak/Splash
Patient problems: Upper Respiratory Tract Irritation
MAUDE report 25770997 ↗MalfunctionJan 2, 2026Leak/Splash
THE USER FACILITY REPORTED THAT THE CAP TO THEIR RAPICIDE PA HIGH-LEVEL DISINFECTANT POPPED OFF AND SPILLED ON AN EMPLOYEE'S FOREARM RESULTING IN WHITE SPOTS. MEDICAL TREATMENT WAS SOUGHT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED
Patient problems: Skin Discoloration
MAUDE report 23950171 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE CAP TO THEIR RAPICIDE PA HIGH-LEVEL DISINFECTANT POPPED OFF AFTER AN EMPLOYEE PLACED THE BOTTLE IN A SINK. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946995 ↗MalfunctionDec 12, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE WAS HANDLING A BOTTLE OF RAPICIDE WHEN THE PRODUCT SPLASHED ON HIS FACE AND FEET. THE EMPLOYEE STATED HE EXPERIENCED A "STINGING SENSATION" AND SOUGHT MEDICAL TREATMENT. IT IS UNKNOWN THE TREATMENT THAT MAY HAVE BEEN ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 23788756 ↗MalfunctionNov 13, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA CHEMTREC THAT THERE WERE TWO COMPLAINTS OF "SORE THROATS" AND "RASPY VOICE" FOLLOWING RAPICIDE PA HIGH-LEVEL DISINFECTANT BOTTLES THAT LEAKED. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEES CONTINUED WORKING.
Patient problems: Loss of consciousness; Sore Throat; Voice alteration
MAUDE report 23544886 ↗MalfunctionSep 18, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT A BOTTLE OF RAPICIDE PA HIGH-LEVEL DISINFECTANT ALLEGEDLY "EXPLODED" WHILE AN EMPLOYEE WAS HANDLING THE PRODUCT. THE EMPLOYEE WENT THE EMERGENCY DEPARTMENT AND WAS PLACED THROUGH THE DECONTAMINATION SHOWER. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED ADDITIONAL MEDICAL TREATMENT.
Patient problems: Burn(s); Insufficient Information
MAUDE report 23085889 ↗MalfunctionJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY CONTACTED STERIS AS PART OF THEIR INVESTIGATION INTO "ONE OF OUR EMPLOYEES RECENTLY REPORTED SOME HEALTH CONCERNS THAT S/H BELIEVES MAY BE RELATED TO AN EXPOSURE IN THE WORKPLACE". IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Chemical Exposure
MAUDE report 22679574 ↗MalfunctionMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE'S EYES WERE EXPOSED TO RAPICIDE PA HIGH-LEVEL DISINFECTANT. CHEMTREC OFFERED MEDICAL ASSISTANCE, AND A COPY OF THE SAFETY DATA SHEET.
Patient problems: Eye Irritation
MAUDE report 21953904 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT RAPICIDE PA HIGH-LEVEL DISINFECTANT "SPILLED" ONTO AN EMPLOYEE'S LEG. SHE EXPERIENCED "TINGLING, BURNING AND REDNESS". THE EMPLOYEE FLUSHED HER LEG WITH WATER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Pain
MAUDE report 21860159 ↗
Other Medivators Inc. products
All Medivators Inc. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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