Z-2676-2026Class II

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

Name: Z-2676-2026 Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope...
Creator: Olympus Corporation of the Americas
Published: 2026-06-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-06-05 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus... on 2026-06-05. FDA classified it as Class II and gives the reason as "Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2676-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-05
Posted: 2026-07-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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...
Quantity in commerce: 988700 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI: 04953170441271, Lot Numbers: H2530 or later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2676-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2676-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-07

Product code FDT

K220587Class IIEvis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. / cleared 2022-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)