FDA recall, , Moderate risk
Olympus Single Use Distal Cover
The Olympus Single Use Distal Cover has a newly designed replacement version.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall on June 5, 2026, of the Olympus Single Use Distal Cover, used with the EVIS EXERA III Duodenovideoscope. The recall was added to the FDA's Enforcement Report on July 7, 2026, and involved 988,700 units distributed nationwide in the US.
The reason for the recall is that Olympus has developed and released a newly designed version of the Distal Cover to replace the previous design of the Single Use Distal Covers. The cover is designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your tube affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator;
duodenoscope and accessories, flexible/rigid- UDI-DI
- 04953170441271
- Lot code
- H2530
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99106
- Recall number
- Z-2676-2026
- Quantity recalled
- 988700 units
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
