EVIS EXERA III Gastrointestinal Videoscope recall
EVIS EXERA III Gastrointestinal Videoscope
Why was EVIS EXERA III Gastrointestinal Videoscope recalled?
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
- Product
- EVIS EXERA III Gastrointestinal Videoscope
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1687 units
- Distribution
- Nationwide Distribution.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)