Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe

FDA device recall Z-2676-2026 · posted 2026-07-07 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

Olympus issued an UREGNT: MEDICAL DEVICE REMOVAL notice to it consignees on 6/5/2026 via 2nd day courier. The notice explained the issue, risk to heath, and requested the following be taken: "1. Examine your inventory for the previous design of the Single Use Distal Covers, model MAJ-2315 (see Fig.1-6 above and list of affected lot numbers). 2. All older versions of this product should be returned to Olympus and replaced with the newly designed version. " Transition to the newly designed version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. 3. Once you have received the new design of the MAJ-2315, stop using the previous design and set aside for return. " To return the older version, please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of the previous design. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: " Go to https://olympusamerica.com/recall " Enter the recall number "XXXX " Complete the form as instructed. " Please indicate in your response if you no longer have the device(s). 5. Please forward this notice to other users who may have the affected products if you have further distributed it." For additional information...

Root cause

Device Design

Status

Open, Classified

Product code

FDT

Quantity affected

988700 units

Distribution

US Nationwide distribution.

Date initiated

2026-06-05

Date posted

2026-07-07

Location

Center Valley, PA

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