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Olympus Single Use Distal Cover
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MEDICAL DEVICE RECALLMODERATE

Olympus Single Use Distal Cover

Olympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.

What to do

Contact your Olympus representative to arrange for the replacement of existing inventory with the newly designed distal covers.

Recalled
Listed
Updated
Recall No.
Z-2676-2026
Agency
FDA
Firm
Olympus Corporation of the Americas
Recall ID
99106
Status
ONGOING

Recall at a glance

Quantity recalled
988700 units

Why it was recalled

Olympus is replacing the previous design of the Single Use Distal Cover, catalog number MAJ-2315, with a newly designed version. This component is used with the EVIS EXERA III Duodenovideoscope, model TJF-Q190V, to cover the distal end of the insertion tube and the forceps elevator.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
H2530
UDI-DI
04953170441271

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-07-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification