FDAClass IIJuly 15, 2026

Olympus Single Use Distal Cover recall

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus…

Why was Olympus Single Use Distal Cover recalled?

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

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: 04953170441271, Lot Numbers: H2530 or later

Product
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus…
Recalling firm
Olympus Corporation of the Americas
Quantity
988700 units
Distribution
US Nationwide distribution.
Recall date
July 15, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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