Olympus ENDOEYE HD II Rigid Videoscope recall
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment…
Why was Olympus ENDOEYE HD II Rigid Videoscope recalled?
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
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?
UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
- Product
- Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- WA50040A : 561 units; WA50042A: 857 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- January 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)