Z-0498-2025Class II

Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190...

Name: Z-0498-2025 Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190...
Creator: Olympus Corporation of the Americas
Published: 2024-09-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-09-18 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A... on 2024-09-18. FDA classified it as Class II and gives the reason as "To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors...". 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-0498-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-18
Posted: 2024-11-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Root cause tag: labeling and UDI
FDA root cause: Reprocessing Controls
Action: On October 18, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Implement use of the enclosed Addendum stating that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new water purge requirements. 3. Olympus requests that you acknowledge receipt of this letter. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0461 c. Complete the form as instructed and include your account ID number: [XXXXXXXX] 4. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including infections or persistent microbial colonization associated with any Olympus endoscope to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at [email protected].
Quantity in commerce: 1749 units
Distribution: Domestic: US Nationwide Distribution.
Product codes and lots: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0498-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0498-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20

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)