EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recallZ-0288-2024 · Olympus Corporation of the Americas · initiated Oct 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
FDA root cause category: Reprocessing Controls
What the company is doing
The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to [email protected] or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].
Recall details
- Recall number
- Z-0288-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 2, 2023
- Posted by the FDA
- Nov 9, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1687 units
- Product code
- FDF
- FDA submissions
- K112680
- Distribution
- Nationwide Distribution.
Product description
EVIS EXERA III Gastrointestinal Videoscope
Code information (models, lots, serial numbers)
Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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