Olympus recalls EVIS EXERA III Gastrointestinal Videoscope model GIF-1TH190 due to unsafe high-level disinfection (HLD) with Acecide-C disinfectant in the OER-Pro reprocessor. Affected units have specific serial numbers or UDI codes.
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Olymp: Olympus is recalling its EVIS EXERA III Gastrointestinal Videoscope model GIF-1TH190 because using Acecide-C disinfectant with the OER-Pro reprocessor can cause unsafe high-level disinfection. This means the scope might not be properly cleaned, increasing infection risks during medical procedures.
The OER-Pro reprocessor is designed to use specific disinfectants for safe cleaning. When Acecide-C disinfectant is used with this model, the high-level disinfection process may not work properly, potentially leaving the scope contaminated and increasing infection risks during medical procedures.
Healthcare professionals using the EVIS EXERA III Gastrointestinal Videoscope model GIF-1TH190 with serial numbers before 2446103 or after 2500453 are most at risk. Patients undergoing procedures with this scope could face infection risks if improper disinfection occurs.
Check the serial number on the scope's packaging or label. Affected units have serial numbers before 2446103 or after 2500453. The Unique Device Identifier (UDI) codes 04953170343360 or 04953170437014 also indicate affected units.
Look for the serial number on the scope's packaging or label. Affected units have serial numbers before 2446103 or after 2500453.
Olympus removed Acecide-C disinfectant as a compatible reprocessing method for this scope in the OER-Pro reprocessor, which can cause unsafe high-level disinfection.
Check the serial number on the scope's packaging or label. Affected units have serial numbers before 2446103 or after 2500453. The Unique Device Identifier (UDI) codes 04953170343360 or 04953170437014 also indicate affected units.
The recall does not specify a remedy, so affected users should contact Olympus directly for guidance on safe handling or disposal.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0620-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0620-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
