Rapicide OPA/28 High-Level Disinfectant ML02-0127Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00677964054266), received between Jan 3, 2017 and Jul 13, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Use of Device Problem; Use of Device Problem

  STERIS RECEIVED A PHONE CALL FROM A PERSON WHO WAS CALLING FROM THEIR HOME AND STATED SHE HAD "INGESTED" RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT. THE CALLER HAD STATED THAT SHE PURCHASED THE RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT ON THE INTERNET. THE CALLER WAS ADVISED BY THE STERIS TECHNICAL SERVICE REPRESENTATIVE TO SEEK MEDICAL ATTENTION.

  Patient problems: Insufficient Information

  MAUDE report 17315935 ↗
• MalfunctionMay 5, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE INGESTED RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT THAT WAS PRESENT ON AN INSTRUMENT THAT HAD NOT BEEN PROPERLY RINSED. THE EMPLOYEE REPORTED A NUMBING AND TINGLING SENSATION ON THEIR LIPS, TONGUE, AND THROAT IN ADDITION TO A POOR TASTE IN THEIR MOUTH. THE EMPLOYEE WAS ADVISED TO VISIT THE EMERGENCY ROOM.

  Patient problems: Chemical Exposure

  MAUDE report 16875487 ↗
• MalfunctionFeb 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN INDIVIDUAL "DEVELOPED A HEADACHE" AND "IRRITATION TO HER UVULA" FROM INGESTION EXPOSURE TO RAPICIDE OPA HIGH LEVEL DISINFECTANT. THE INDIVIDUAL SOUGHT MEDICAL TREATMENT, BUT IT IS UNKNOWN IF TREATMENT WAS ADMINISTERED.

  Patient problems: Headache

  MAUDE report 16426588 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED TREATING A PATIENT WHO WAS SPLASHED IN THE EYE WITH RAPICIDE OPA-28 HIGH LEVEL DISINFECTANT WHILE CLEANING ENDOSCOPES.

  Patient problems: Chemical Exposure

  MAUDE report 9257403 ↗
• Jan 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE STATES THAT A FACULTY MEMBER EXPERIENCED BURNING EYES AND THROAT, AND RESPIRATORY INHALATION EXPOSURE SYMPTOMS WHILE CLEANING UP A RAPICIDE OPA HIGH LEVEL DISINFECTANT SPILL.

  Patient problems: Chemical Exposure

  MAUDE report 6220197 ↗