Olympus recalls single-use distal covers MAJ-2315 used with EVIS EXERA III duodenoscopes due to risk of mucosal injury, detachment, aspiration, or burns.
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Olympus is recalling single-use distal covers MAJ-2315 that come with EVIS EXERA III duodenoscopes. These covers can detach during use, potentially causing mucosal injury, aspiration, inhalation, or burns.
The cover may detach during use, leading to mucosal injury. If detached, it could cause aspiration, inhalation, or obstruction requiring urgent removal. An uncovered endoscope tip might cause burns.
Medical professionals using Olympus EVIS EXERA III duodenoscopes with the MAJ-2315 covers are most at risk. Patients undergoing procedures with these covers could experience complications.
Check for the model number MAJ-2315 on the cover. The cover is used with EVIS EXERA III duodenoscopes (TJF-Q190V) and has item code N5786100 from lots lower than H2530.
Inspect the cover for signs of detachment or damage before use.
Reach out to Olympus Corporation of the Americas for replacement or return options.
The model number is MAJ-2315.
This cover is used with EVIS EXERA III duodenoscopes for procedures like duodenal imaging.
Look for the model number MAJ-2315 on the cover, which is used with EVIS EXERA III duodenoscopes (TJF-Q190V) and has item code N5786100 from lots lower than H2530.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1613-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1613-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
