Z-0620-2025Class II

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Name: Z-0620-2025 EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Creator: Olympus Corporation of the Americas
Published: 2024-10-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-10-31 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 on 2024-10-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0620-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-31
Posted: 2024-12-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: 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 ).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Olympus notified consignees via letter on about 10/31/2024. Consignees were informed of the issue and of the upcoming revision of the labeling such that the GIF-1TH190 is no longer a compatible endoscope for reprocessing with Acecide-C in the OER-Pro. They were instructed that they would be contacted by their Olympus sales representative within the month to discuss potential OER-Elite and GIF-1TH190 transition programs. Additionally, they were instructed to carefully read the notification, ensure reprocessing staff and other users of the OER-Pro AER are aware of the corrective action, acknowledge receipt of the notification through the Olympus web portal, and to identify and notify recipients of the affected devices if they were further distributed.
Quantity in commerce: 1,770 units
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Product codes and lots: Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0620-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0620-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05

Product code FDS

K232997Class IIEVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation / cleared 2024-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)