SINGLE USE DISTAL COVER recallZ-2676-2026 · Olympus Corporation of the Americas · initiated Jun 5, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
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...
Recall details
- Recall number
- Z-2676-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2026
- Posted by the FDA
- Jul 7, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 988700 units
- Product code
- FDT
- FDA submissions
- K220587
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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