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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus GIF1TH190

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 Class 2 Device Recall Olympus GIF1TH190see related information
Date Initiated by FirmOctober 31, 2024
Date PostedDecember 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0620-2025
Recall Event ID 95641
510(K)NumberK232997 
Product Classification Gastroscope and accessories, flexible/rigid - Product Code FDS
ProductEVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Code Information Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer 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 ).
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus 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 Commerce1,770 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDS
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