Advantage Plus Endoscope Reprocessing System 1-2-510.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00677964044755), received between Dec 2, 2016 and Sep 23, 2026 — classified as 41 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 reports).

4 other recalls cover devices cleared under the same FDA submission (K082988, K102996); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872657 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822468 ↗
• MalfunctionAug 18, 2026Mechanical Problem

  The user facility reported that the door to their Advantage Plus Endoscope Reprocessing System opened mid cycle and sprayed water. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300718 ↗
• InjuryJul 31, 2026Use of Device Problem

  The user facility reported via Vigilance Report that the incorrect detergent was utilized within their Advantage Plus Automated Endoscope Reprocessor to process endoscopes. The endoscopes were subsequently used during patient procedures. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097949 ↗
• MalfunctionMay 21, 2026Break

  THE USER FACILITY REPORTED THE RIGHT GLASS LID COVER TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM SHATTERED WHILE RUNNING A CYCLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244099 ↗
• MalfunctionApr 29, 2026Unintended Movement

  THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS PREPARING TO REPROCESS AN ENDOSCOPE, THE DOOR OF THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM CONTACTED THEIR HANDS. THE EMPLOYEE EXPERIENCED REDNESS ON THEIR HANDS HOWEVER, NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Abrasion

  MAUDE report 25035470 ↗
• MalfunctionApr 23, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM LEAKED WATER AND DISINFECTANT. EMPLOYEES THAT WERE EXPOSED TO THE DISINFECTANT FUMES SOUGHT MEDICAL TREATMENT AT THE USER FACILITY EMERGENCY DEPARTMENT; HOWEVER, IT IS UNKNOWN WHAT MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Chemical Exposure

  MAUDE report 24964813 ↗
• MalfunctionApr 21, 2026Device Reprocessing Problem

  THE USER FACILITY VIA CHEMTREC REPORT THAT USER FACILITY PERSONNEL HAD INADVERTENTLY SWITCHED THE ALCOHOL AND DETERGENT SUPPLY BOTTLES DURING REPROCESSING OF ENDOSCOPES WITH THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM AND ONE SCOPE WAS SUBSEQUENTLY USED DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942498 ↗
• MalfunctionMar 26, 2026Leak/Splash

  THE USER FACILITY REPORTED AN EMPLOYEE WAS CLEANING UP FLUID FROM THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM DRIP TRAY AND BEGAN TO FEEL LIGHTHEADED. THE EMPLOYEE SOUGHT FRESH AIR. IT IS UNKNOWN IF ADDITIONAL MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Dizziness

  MAUDE report 24698422 ↗
• MalfunctionMar 26, 2026Leak/Splash

  THE USER FACILITY REPORTED AN ODOR EMITTING FROM THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM. EMPLOYEES PRESENT EXPERIENCED VOMITING, HEADACHES, NECK PAIN AND STINGING EYES. THE EMPLOYEES SOUGHT AND RECEIVED MEDICAL TREATMENT.

  Patient problems: Eye Irritation

  MAUDE report 24698421 ↗
• MalfunctionMar 18, 2026Use of Device Problem

  THE USER FACILITY REPORTED THAT THE LID TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM CLOSED ON AN EMPLOYEE'S HAND CAUSING A SMALL CUT. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (BANDAGE).

  Patient problems: Laceration(s)

  MAUDE report 24630939 ↗
• MalfunctionMar 4, 2026Device Reprocessing Problem

  THE USER FACILITY REPORTED THAT USER FACILITY PERSONNEL HAD INADVERTENTLY SWITCHED THE ALCOHOL AND DETERGENT SUPPLY BOTTLES DURING REPROCESSING OF ENDOSCOPES WITH THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM AND TWO SCOPES WERE SUBSEQUENTLY USED DURING PATIENT PROCEDURES. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508052 ↗
• MalfunctionFeb 20, 2026Filtration Problem

  THE USER FACILITY REPORTED THAT THREE OF THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEMS WERE NOT WORKING PROPERLY. BECAUSE THE FACILITY HAD NO OTHER AVAILABLE METHODS OF REPROCESSING DEVICES, PROCEDURES WERE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402043 ↗
• MalfunctionJan 9, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT EMPLOYEES EXPERIENCED HEADACHES FROM RAPICIDE THAT LEAKED. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Headache

  MAUDE report 24026023 ↗
• MalfunctionNov 28, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAKING FROM THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672103 ↗
• MalfunctionNov 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER FACILITY REPORTED THAT THEY WERE USING THE INCORRECT HOOKUP AND PARAMETER SETTINGS DURING REPROCESSING OF ENDOSCOPES WITH THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM AND THE SCOPES WERE SUBSEQUENTLY USED DURING PATIENT PROCEDURES. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657115 ↗
• MalfunctionNov 21, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE LEFT THEIR ARM IN THE WAY OF THE CLOSING LID OF THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM. MEDICAL TREATMENT WAS SOUGHT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Abrasion

  MAUDE report 23618864 ↗
• MalfunctionNov 12, 2025Break; Break

  THE USER FACILITY REPORTED VIA MEDWATCH MW5177615 THAT THE LID TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM SHATTERED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537318 ↗
• MalfunctionOct 31, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THEIR AIR COMPRESSOR TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM WAS DAMAGED SUBSEQUENTLY CAUSING PROCEDURES TO BE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438888 ↗
• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THE LID TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM CONTACTED AN EMPLOYEE'S HAND. THE EMPLOYEE SOUGHT MEDICAL TREATMENT, HOWEVER IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Pain

  MAUDE report 22816594 ↗
• MalfunctionAug 13, 2025Arcing; Arcing

  THE USER FACILITY REPORTED AN EMPLOYEE BURNED THEIR HAND AND "GOT SHOCKED" WHILE PLUGGING IN THE AIR COMPRESSOR TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM. ADDITIONALLY, THE USER FACILITY STATED, "THE CABLE WAS POSSIBLY EXPOSED TO MOISTURE". OUT OF CAUTION, THE EMPLOYEE SOUGHT AN EKG TEST FOLLOWING THE REPORTED EVENT; HOWEVER, THE RESULTS ARE UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 22797873 ↗
• MalfunctionJul 17, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THEY HAD REPROCESSED AN ENDOSCOPE THAT WAS USED ON A PATIENT WHO TESTED POSITIVE FOR CREUTZFELDT-JAKOB DISEASE (CJD) IN THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM. IT WAS REPORTED BY THE USER FACILITY THAT FOLLOWING REPROCESSING, THIS ENDOSCOPE WAS SUBSEQUENTLY USED ON ANOTHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535769 ↗
• MalfunctionJul 2, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED INHALATION/IRRITATION EFFECTS WHILE CLEANING WATER AND DISINFECTANT THAT LEAKED FROM THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM ONTO THE FLOOR. THE EMPLOYEES WENT TO THE EMERGENCY ROOM; HOWEVER, IT WAS NOT DISCLOSED WHETHER MEDICAL TREATMENT WAS RECEIVED. THE EMPLOYEES RETURNED TO WORK THE NEXT DAY.

  Patient problems: Aspiration/Inhalation

  MAUDE report 22382479 ↗
• MalfunctionMay 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING FOR THREE OF THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEMS FOLLOWING REPORTS OF "RESIDUE" BEING OBSERVED IN THE UNITS. THE UNITS WERE REMOVED FROM SERVICE RESULTING IN PROCEDURE POSTPONEMENTS. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117378 ↗
• MalfunctionMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE FELT A BURNING SENSATION ON THEIR HANDS AFTER REMOVING AN INSTRUMENT FROM THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM. THE EMPLOYEE THEN OBSERVED THAT THEIR HANDS BECAME "SWOLLEN" AND SOUGHT TREATMENT AT THE ER. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Burning Sensation

  MAUDE report 22114858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082988, K102996. One submission often covers many models, so check the product and lot details in each record.

• Z-2538-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru
• Z-2536-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Au
• Z-2537-2024 · Jun 13, 2024 · Open, Classified
  Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru
• 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