Rapicide PA High-Level Disinfectant ML02-0117 (REF ML020117)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00677964090172), received between Oct 1, 2021 and Apr 17, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 16, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE EXPERIENCED EYE AND THROAT IRRITATION AFTER RAPICIDE PA HIGH-LEVEL DISINFECTANT "SPILLED" WITHIN THEIR UNIT. CHEMTREC OFFERED MEDICAL ASSISTANCE AND A COPY OF THE SAFETY DATA SHEET (SDS) HOWEVER, THE EMPLOYEE DECLINED. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. PROCEDURE CANCELLATIONS WERE REPORTED.

  Patient problems: Eye Irritation

  MAUDE report 19333207 ↗
• MalfunctionJan 5, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS HANDLING A BOX OF RAPICIDE PA HIGH-LEVEL DISINFECTANT PART A, UPON RECEIPT THE BOTTLES WERE PACKED UPSIDE DOWN CAUSING A BURN ON AN EMPLOYEE'S HAND. THE EMPLOYEE WASHED THE AFFECTED AREA AND RETURNED BACK TO WORK. THE EMPLOYEE WAS REPORTED TO NOT HAVE BEEN WEARING GLOVES AT THE TIME OF THE EVENT. NO ADDITIONAL REPORTS OF INJURY WERE REPORTED. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 16106426 ↗
• MalfunctionApr 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT RAPICIDE PA HIGH-LEVEL DISINFECTANT PART A SPRAYED ONTO AN EMPLOYEE AS THEY WERE TAKING THE CAP OFF. THE EMPLOYEE REPORTED THEIR SKIN WAS "BURNING". THE EMPLOYEE RINSED THE AFFECTED AREA AND SOUGHT ADDITIONAL MEDICAL TREATMENT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 13978098 ↗
• MalfunctionDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS EXCHANGING RAPICIDE PA HIGH-LEVEL DISINFECTANT/STERILANT BOTTLES IN THE ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR (AER) AND REPORTED INHALATION EXPOSURE TO THE DISINFECTANT FUMES. THE EMPLOYEE SOUGHT MEDICAL ASSESSMENT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS DETERMINED TO BE REQUIRED OR ADMINISTERED. IT WAS CONFIRMED THAT THE EMPLOYEE WAS ABLE TO RETURN TO WORK.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13002497 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT RAPICIDE PA HIGH-LEVEL DISINFECTANT, PART A AND B, WERE SPILLED INTO THE FACILITY STORAGE AREA. TWO (2) EMPLOYEES RESPONDED TO THE CHEMICAL SPILL AND WERE REPORTED TO BE EXPOSED TO THE DISINFECTANT. THE FIRST EMPLOYEE REPORTED INHALATION EXPOSURE AND EYE IRRITATION. NO SYMPTOMS WERE REPORTED FOR THE SECOND EMPLOYEE BUT THEY DID REPORT A "STRONG VINEGAR SMELL" FROM THE DISINFECTANT SPILL. THE EMPLOYEES WERE REPORTED TO BE WEARING PPE. MEDIVATORS WAS NOTIFIED OF THE REPORTED EVENT THROUGH A CHEMTREC REPORT. DETAILS REGARDING THE USER SYMPTOMS, IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED FOR EITHER EMPLOYEE INVOLVED IN THE REPORTED EVENT, AND CAUSE OF THE DISINFECTANT SPILL WERE NOT DISCLOSED TO MEDIVATORS.

  Patient problems: Chemical Exposure; Unspecified Eye / Vision Problem

  MAUDE report 13002425 ↗
• MalfunctionDec 2, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS HANDLING RAPICIDE PA HIGH LEVEL DISINFECTANT WITHOUT WEARING GLOVES. THEY REPORTED WHITE MARKS ON THEIR RIGHT FINGER FOLLOWING HANDLING OF THE DISINFECTANT. MEDIVATORS WAS NOTIFIED OF THE REPORTED EVENT THROUGH CHEMTREC. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 12919192 ↗
• InjuryOct 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT RAPICIDE PA HIGH-LEVEL DISINFECTANT PART A SPLASHED ON AN EMPLOYEE'S FOREARM. THE EMPLOYEE EXPERIENCED REDNESS AND RAISING OF THE SKIN. THE EMPLOYEE WASHED THE AFFECTED AREA. THE EMPLOYEE WAS REPORTED TO BE WEARING GLOVES, BUT IT IS UNKNOWN IF OTHER PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN AT THE TIME OF THE EXPOSURE. NO ADDITIONAL REPORTS OF INJURY WERE REPORTED.

  Patient problems: Erythema

  MAUDE report 12725401 ↗
• MalfunctionOct 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A TECHNICIAN REMOVED A BOTTLE OF MEDIVATORS RAPICIDE PA PART A FROM THE BOX AND WAS SPLASHED BY THE CHEMISTRY ON THEIR NECK AND ARM. THE TECHNICIAN TOOK A SHOWER TO RINSE OFF THE CHEMICALS AND NOTED SLIGHT REDNESS AND IRRITATION OF THE SKIN ON HER ARM AND NECK DUE TO THE CHEMISTRY EXPOSURE. IT IS UNKNOWN IF PPE WAS WORN AT THE TIME OF THE EVENT. THE TECHNICIAN REPORTED THAT THE CHEMISTRY BOTTLE CAP HAD BEEN LOOSE, RESULTING IN THE REPORTED EVENT. NO ADDITIONAL REPORTS OF INJURY WERE REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12719715 ↗
• MalfunctionOct 1, 2021Fracture; Fracture

  A USER FACILITY REPORTED THAT A BOTTLE OF MEDIVATORS RAPICIDE PA PART A HAD CRACKED AND LEAKED INTO THE FACILITY'S STORAGE CABINET. WHEN ATTEMPTING TO IDENTIFY THE SOURCE OF THE LEAK, A USER INHALED THE FUMES AND REPORTED EXPERIENCING THROAT DISCOMFORT AND AN IRREGULAR HEARTBEAT. THE USER WAS EVALUATED ON-SITE AT THE FACILITY; A CHEST X-RAY WAS OBTAINED BUT NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Arrhythmia; Sore Throat

  MAUDE report 12565299 ↗

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, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
• Z-0156-2027 · Sep 21, 2026 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
• Z-0155-2027 · Sep 21, 2026 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
• Z-0617-2024 · Nov 13, 2023 · Open, Classified
  Hookup 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