Rapicide High Level Disinfectant and Sterilant ML02-0059Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00677964034855), received between Sep 12, 2016 and Jan 16, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Chemical Spillage” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT WHILE CHANGING OUT THE BOTTLE OF RAPICIDE HIGH-LEVEL DISINFECTANT TO THEIR DSD 201 AUTOMATED ENDOSCOPE REPROCESSOR, AN EMPLOYEE WAS "EXPOSED" TO RAPICIDE HIGH-LEVEL DISINFECTANT AND EXPERIENCED INHALATION/IRRITATION. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24095325 ↗
• InjuryJul 24, 2019Leak/Splash; Inadequate or Insufficient Training; Leak/Splash; Inadequate or Insufficient Training

  A FACILITY REPORTED THAT FOUR FACILITY PERSONNEL WERE EXPOSED TO MEDIVATORS RAPICIDE HIGH LEVEL DISINFECTANT (HLD) WHEN AN OPERATOR INADVERTENTLY SPILLED THE HLD WHILE FILLING THE RESERVOIR IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). IT WAS REPORTED THAT ONE OF THE PERSONNEL EXPERIENCED DIZZINESS, THROAT IRRITATION AND A COUGH.

  Patient problems: Chemical Exposure; Dizziness; Sore Throat

  MAUDE report 8821650 ↗
• InjuryJul 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDIVATORS RECEIVED A REPORT FROM CHEMTREC THAT A USER EXPERIENCED EYE EXPOSURE WHILE HANDLING RAPICIDE HIGH LEVEL DISINFECTANT (HLD).

  Patient problems: Chemical Exposure; Discomfort

  MAUDE report 8777850 ↗
• InjuryJun 27, 2018Off-Label Use; Off-Label Use

  MEDIVATORS CLINICAL EDUCATION SPECIALIST REPORTED AFTER THE FACILITY REPROCESSED ENDOSCOPES IN THEIR AUTOMATED ENDOSCOPE REPROCESSOR WITH RAPICIDE GLUTARALDEHYDE CHEMISTRY, THEY USED RAPICIDE OPA TEST STRIPS TO CHECK THE MINIMUM REQUIRED CONCENTRATION OF THE HIGH-LEVEL DISINFECTANT. IN ACCORDANCE WITH THE IFU, RAPICIDE TEST STRIPS SHOULD BE USED TO TEST THE MRC OF THE CHEMISTRY. THERE IS POTENTIAL THE REPROCESSING CYCLES DID NOT REACH HIGH-LEVEL DISINFECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643910 ↗
• InjuryFeb 23, 2018Chemical Spillage; Chemical Spillage

  THE FACILITY REPORTED AN INDIVIDUAL SPILLED RAPICIDE HIGH LEVEL DISINFECTANT ON THEMSELVES AND EXPERIENCED CHEMICAL EXPOSURE TO THEIR SKIN. THE FACILITY REQUESTED INFORMATION ABOUT THE EFFECTS OF EXPOSURE TO RAPICIDE HLD.

  Patient problems: Chemical Exposure

  MAUDE report 7292725 ↗
• Sep 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE STATES THAT TWO (2) NURSES EXPERIENCED CHEMICAL EXPOSURE SYMPTOMS FROM RAPICIDE GLUTARALDEHYDE HIGH LEVEL DISINFECTANT. THE EXPOSURE SYMPTOMS INCLUDED HEADACHES.

  Patient problems: Chemical Exposure

  MAUDE report 5943677 ↗