Rapicide PA High-Level Disinfectant ML02-0117 (REF ML020117)Recalls & reported problems
Medivators Inc. · Rapicide PA High-Level Disinfectant. Parts A and B. · Class 2
All models of Rapicide PA High-Level Disinfectant (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medivators Rapicide PA high-level disinfectant is a two-part chemical solution used to disinfect endoscopes. Most of the 64 reports describe bottles leaking, splashing or popping their caps open while staff were handling them, sometimes releasing fumes or spilling. The reports mention 27 injuries and no deaths, with symptoms including chemical burns, skin irritation and discoloration, stinging, and sore throats. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00677964063619), received between Sep 29, 2016 and Jul 9, 2026 — classified as 27 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 reports).
4 other recalls cover devices cleared under the same FDA submission (K082988); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash18
- Adverse Event Without Identified Device or Use Problem11
- Insufficient Device Problem Information8
- Chemical Spillage7
- Fumes or Vapors7
- Use of Device Problem5
- Device Damaged Prior to Receipt by User4
- Device Handling Problem4
Patient problems
- Chemical Exposure31
- Burn(s)11
- Skin Discoloration5
- Burning Sensation4
- No Clinical Signs, Symptoms or Conditions4
- Eye Irritation3
- Skin Irritation3
- Chest Tightness/Pressure2
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Leak/Splash
Patient problems: Upper Respiratory Tract Irritation
MAUDE report 25771008 ↗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 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN ON THEIR HANDS WHILE REMOVING A BOTTLE OF RAPICIDE PA HIGH LEVEL DISINFECTANT PART A FROM A DAMAGED BOX. THE EMPLOYEE WASHED THEIR HANDS WITH WATER AND CONTINUED WORKING; SYMPTOMS FULLY RESOLVED THE NEXT DAY.
Patient problems: Burn(s)
MAUDE report 20796174 ↗MalfunctionOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A HEADACHE AFTER BEING EXPOSED TO RAPICIDE. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.
Patient problems: Headache
MAUDE report 20429849 ↗MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE WAS OPENING A BOTTLE OF RAPICIDE PA HIGH LEVEL DISINFECTANT AND EXPERIENCED DISCOLORATION AND A TINGLING SENSATION TO HER FINGERTIPS. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Discoloration
MAUDE report 20254941 ↗MalfunctionSep 6, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS INADVERTENTLY SPLASHED IN THE EYE WHILE HANDLING RAPICIDE RESULTING IN A "BURNING SENSATION." THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT THE EMERGENCY ROOM; HOWEVER, USER FACILITY PERSONNEL DID NOT DISCLOSE WHAT MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 20158979 ↗MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT EXPIRED RAPICIDE PA HIGH-LEVEL DISINFECTANT WAS UTILIZED TO REPROCESS SCOPES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19374717 ↗MalfunctionMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED AN IRRITATED THROAT AFTER "INHALING FUMES" WHILE OPENING A BOX OF RAPICIDE PA HIGH LEVEL DISINFECTANT. THE USER FACILITY DISCLOSED THAT MEDICAL TREATMENT WAS SOUGHT BUT NOT ADMINISTERED.
Patient problems: Sore Throat
MAUDE report 18962003 ↗MalfunctionMar 20, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT THEY WERE USING AN EXPIRED BOTTLE OF RAPICIDE PA HIGH LEVEL DISINFECTANT FOR APPROXIMATELY TWO DAYS WHILE PROCESSING INSTRUMENTS IN THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946590 ↗MalfunctionMar 7, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING A PACKAGE THAT LEAKED CONTAINING RAPICIDE PA HIGH LEVEL DISINFECTANT AND OBTAINED A BURN ON THEIR FOREARM. THE EMPLOYEE RINSED THE AFFECTED AREA AND MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (OINTMENT) AT THE FACILITY'S ER.
Patient problems: Burn(s)
MAUDE report 18859842 ↗MalfunctionMar 1, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT UPON MOVING AND OPENING A PACKAGE THAT LEAKED CONTAINING RAPICIDE PA HIGH-LEVEL DISINFECTANT, AN EMPLOYEE EXPERIENCED IRRITATION ON THEIR HANDS. MEDICAL TREATMENT WAS SOUGHT BUT NOT ADMINISTERED AS THE IRRITATION SUBSIDED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 18817825 ↗MalfunctionFeb 23, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED "MINOR BURNS" ON THEIR HANDS FROM RAPICIDE PA HIGH LEVEL DISINFECTANT. THE EMPLOYEE WASHED THEIR HANDS UNTIL SYMPTOMS WERE RESOLVED.
Patient problems: Burn(s)
MAUDE report 18769005 ↗MalfunctionDec 15, 2023Device Handling Problem; Device Handling Problem
A RECYCLING PLANT REPORTED VIA CHEMTREC REPORT THAT A STRONG ODOR WAS DETECTED COMING FROM CONTAINERS OF RAPICIDE PA HIGH LEVEL DISINFECTANT AND SEVERAL EMPLOYEES EXPERIENCED INHALATION/IRRITATION. THE EMPLOYEES MOVED TO FRESH AIR AND THEIR SYMPTOMS RESOLVED.
Patient problems: Eye Irritation
MAUDE report 18336255 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING A BOTTLE OF RAPICIDE PA HIGH LEVEL DISINFECTANT AND SOME OF THE BOTTLE CONTENTS "SQUIRTED OUT" OF THE LID TOWARDS THE EMPLOYEE'S FACE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335077 ↗MalfunctionDec 4, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS MOVING THEIR INVENTORY OF RAPICIDE PA HIGH LEVEL DISINFECTANT AND THE BOTTLE "EXPLODED" IN HER FACE. THE EMPLOYEE WAS SENT TO THE ER AND RECEIVED MEDICAL TREATMENT.
Patient problems: Burn(s)
MAUDE report 18263692 ↗MalfunctionNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE "ACCIDENTLY" DROPPED RAPICIDE PA HIGH-LEVEL DISINFECTANT (UNKNOWN IF IT WAS PART A OR PART B) DOWN THE DRAIN. THE EMPLOYEE STATED SHE GOT PRODUCT ON ONE OF HER ARMS WHICH RESULTED IN DISCOLORATION OF THE SKIN. THE EMPLOYEE ALSO STATED A STRONG ODOR WAS PRESENT WHEN THE RAPICIDE PA HIGH-LEVEL DISINFECTANT WAS DROPPED. THE CHEMTREC REPORT STATED THE EMPLOYEE WAS SEEKING MEDICAL ATTENTION ON SITE.
Patient problems: Skin Discoloration
MAUDE report 18103784 ↗MalfunctionNov 3, 2023Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT TWO EMPLOYEES WERE EXPOSED TO SKIN AND INHALATION EXPOSURE AFTER USING THE RAPICIDE PA HIGH-LEVEL DISINFECTANT. THIS EXPOSURE CAUSED A BURNING SENSATION TO THE EMPLOYEES' NOSE, EYES AND THROAT. REPORT OF A HEADACHE AND WHITENING OF SKIN WAS ALSO REPORTED. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 18066615 ↗MalfunctionOct 11, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WHILE EMPLOYEES WERE DISPOSING OF RAPICIDE PA HIGH-LEVEL DISINFECTANT THEY BEGAN TO VOMIT AND EXPERIENCED SHORTNESS OF BREATH, EYE, AND SKIN IRRITATION. THE EMPLOYEES WASHED THEIR ARMS WITH WATER AND WERE SENT TO THE EMERGENCY ROOM. THE SUBJECT EMPLOYEES WERE DISCHARGED FROM THE EMERGENCY ROOM THE SAME DAY.
Patient problems: Eye Irritation; Vomiting
MAUDE report 17915956 ↗MalfunctionAug 30, 2023Leak/Splash; Leak/Splash
FEDEX FREIGHT REPORTED VIA CHEMTREC REPORT THAT A CARRIER EMPLOYEE WAS HANDLING A DAMAGED BOTTLE OF RAPICIDE PA HIGH-LEVEL DISINFECTANT AND OBTAINED BURNS ON THEIR FINGERS. THE CARRIER EMPLOYEE WASHED THEIR HANDS WITH WATER AND WAS ADVISED TO SEEK MEDICAL TREATMENT SHOULD HIS SYMPTOMS WORSEN OR NOT IMPROVE.
Patient problems: Burn(s)
MAUDE report 17657646 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082988. One submission often covers many models, so check the product and lot details in each record.
- Z-0154-2027 · Sep 21, 2026 · Open, ClassifiedRAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
- Z-0156-2027 · Sep 21, 2026 · Open, ClassifiedRAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
- Z-0155-2027 · Sep 21, 2026 · Open, ClassifiedRAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
- Z-0617-2024 · Nov 13, 2023 · Open, ClassifiedHookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-01
Other Accessories, Cleaning, For Endoscope devices
- ENDOSCOPE REPROCESSOR OER-ProOlympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE3 recalls1,163 reports
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2110Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall213 reports
- CONNECTING TUBE MAJ-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- CONNECTING TUBE MAJ-2112Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall143 reports
- ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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